KaVo EXPERTsurg LUX User manual

Instructions for use
EXPERTsurg LUX – 1.008.3500

Distributed by:
KaVo Dental Technologies, LLC
11727 Fruehauf Drive
Charlotte, NC 28273 USA
Phone: [phone]
Fax: [phone]
Manufacturer:
KaVo Dental GmbH
Bismarckring 39
88400 Biberach
Germany
www.kavo.com

Instructions for use EXPERTsurg LUX – 1.008.3500
Table of contents
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Table of contents
1 User instructions ............................................................................................................... 5
2 Safety................................................................................................................................. 7
2.1 Explosion hazard ........................................................................................................... 7
2.2 Infection hazard ............................................................................................................ 7
2.3 Electrical shock.............................................................................................................. 7
2.4 Technical condition ........................................................................................................ 8
2.5 Electromagnetic fields .................................................................................................... 8
2.6 Improper use ................................................................................................................ 9
2.7 Accessories and combination with other equipment........................................................... 9
2.8 Qualification of personnel ............................................................................................... 9
2.9 Service and repair ......................................................................................................... 9
2.10 Information on electromagnetic compatibility ................................................................... 10
3 Product description ........................................................................................................... 11
3.1 Intended use................................................................................................................. 11
3.2 Scope of delivery........................................................................................................... 13
3.3 EXPERTsurg LUX ........................................................................................................... 14
3.4 Hand-held control panel ................................................................................................. 16
3.5 Foot control .................................................................................................................. 17
3.6 Technical Specifications EXPERTsurg LUX ......................................................................... 18
3.7 Symbols on product, packaging and rating plate ............................................................... 19
3.8 Transport and storage.................................................................................................... 20
3.8.1 Damage in transit............................................................................................. 20
4 Startup............................................................................................................................... 22
4.1 Unpacking .................................................................................................................... 22
4.2 Installing the bottle holder.............................................................................................. 22
4.3 Plugging in the foot control ............................................................................................. 22
4.4 Connecting the surgical motor......................................................................................... 23
4.5 Connecting the coolant container and hose set ................................................................. 24
4.6 Electrical connection ...................................................................................................... 28
5 Operation........................................................................................................................... 30
5.1 Turning the device on .................................................................................................... 30
5.2 Making the device settings.............................................................................................. 30
5.3 Surgical motor INTRA LUX S600 LED ............................................................................... 32
5.3.1 Attaching the straight or contra-angle handpiece ................................................. 33
5.3.2 Removing the straight or contra-angle handpiece ................................................ 33
5.4 Defining and running program steps................................................................................ 34
5.4.1 Factory settings................................................................................................ 35
5.4.2 Exemplary program step sequences ................................................................... 36
5.4.3 Selecting the program steps .............................................................................. 37
5.4.4 Selecting activities............................................................................................ 38
5.4.5 Limiting the program steps................................................................................ 38
5.5 Changing default values ................................................................................................. 39
5.5.1 Setting the maximum speed.............................................................................. 39
5.5.2 Setting the torque limit ..................................................................................... 39
5.5.3 Setting the coolant flow rate.............................................................................. 40
5.5.4 Changing the direction of motor rotation............................................................. 41
5.5.5 Setting the transmission ratio ............................................................................ 42
5.6 Rinsing function............................................................................................................. 43

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5.6.1 Manual rinsing function ..................................................................................... 43
5.6.2 Program step Rinsing function ........................................................................... 44
5.7 Activating the one-touch calibration................................................................................. 44
5.8 Foot control .................................................................................................................. 46
5.8.1 Changing the speed, coolant flow rate, and direction of motor rotation................... 46
5.8.2 Selecting the program steps .............................................................................. 46
5.8.3 Changing the coolant container.......................................................................... 47
6 Reprocessing steps in accordance with ISO 17664 .......................................................... 48
6.1 Manual processing ......................................................................................................... 48
6.1.1 Manual cleaning ............................................................................................... 48
6.1.2 Manual disinfection ........................................................................................... 50
6.1.3 Manual drying .................................................................................................. 50
6.2 Automated processing.................................................................................................... 51
6.2.1 Automated cleaning and disinfection................................................................... 51
6.2.2 Service, inspection and testing after processing ................................................... 51
6.3 Packaging ..................................................................................................................... 52
6.4 Sterilization................................................................................................................... 52
6.5 Storage ........................................................................................................................ 53
7 Run a software update ...................................................................................................... 54
8 Accessories........................................................................................................................ 55
9 Safety check ...................................................................................................................... 56
9.1 Repair Service............................................................................................................... 56
10Troubleshooting ................................................................................................................ 57
11Decommissioning .............................................................................................................. 60
11.1 Disconnecting the electrical connection ............................................................................ 60
11.2 Disposal of the coolant hose ........................................................................................... 60
11.3 Disconnecting the surgical motor..................................................................................... 61
11.4 Disconnecting the foot control......................................................................................... 62
11.5 Dismantling the bottle holder.......................................................................................... 62
12Disposal ............................................................................................................................. 63
13Information concerning the electromagnetic compatibility according to IEC 60601-1-2 64
13.1 Operating environment and EMC warning notes................................................................ 64
13.2 Results of the electromagnetic tests ................................................................................ 64
14Terms and conditions of warranty .................................................................................... 67

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1 User instructions
Dear User,
Congratulations on purchasing this KaVo quality product. By following the in-
structions below you will be able to work smoothly, economically and safely.
© Copyright by KaVo Dental GmbH
KaVo and EXPERTsurg are either registered trademarks or trademarks of KaVo
Dental GmbH.
All other trademarks are property of their respective owners.
Target group
The instructions for use are intended for medical professionals, in particular
dentists and office personnel.
General marks and symbols
See Chapter on User Instructions/Hazard Levels
Important information for users and service technicians
Action request
Original language German
CE mark (European Community). A product bearing this mark meets
the requirements of the applicable EC directive.
Medical device, labeling of medical devices
Sterilizable by steam
Thermodisinfectable
Hazard levels
The warning and safety notes in this document must be observed to prevent
personal injury and property damage. The warning notes are designated as
shown below:
HAZARD
In cases which – if not prevented – directly lead to death or severe injury.
WARNING
In cases which – if not prevented – can lead to death or severe injury.
CAUTION
In cases which – if not prevented – can lead to minor or moderate injury.

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NOTICE
In cases which – if not prevented – can lead to property damage.
KaVo Technical Service
Please direct all questions regarding the product, service and maintenance to
the KaVo Technical Service:
Toll-free: 1-888-KAVOUSA (888-528-6872)
Email: [e-mail]
Please refer to the serial number of the product in all inquiries.
Please refer to the serial number of the product in all inquiries! For further infor-
mation, please visit: www.kavo.com
KaVo Repair Service
For repairs, please contact the KaVo Repair Service. For scheduling or if you
have any questions, please contact:
KaVo Dental Technologies, LLC
11727 Fruehauf Drive
Charlotte, NC 28273 USA
Toll-free Direct Customer Service: 1-888-KAVOUSA (888-528-6872)
Email: [e-mail]
www.kavo.com
KaVo offers a fixed-price service check for the original factory maintenance.
You can use a loaner device for the time of the service check.

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2 Safety
NOTE
All serious events occurring in relation to the product must be reported to the
manufacturer and the competent authority of the member state, in which the
user and/or patient resides.
The instructions for use are a component of the product and must be read care-
fully prior to use and be accessible at all times.
The device may only be used in accordance with the intended use, any other
type of use is not permitted.
2.1 Explosion hazard
Electrical sparks in the product can lead to explosion or fire.
4Do not use product in explosion hazard areas.
4Do not operate the product in an oxygen-enriched atmosphere.
4Do not use the product in the vicinity of flammable gases.
2.2 Infection hazard
Patients, users or third parties can be infected by contaminated medical de-
vices.
4Take suitable personal protective measures.
4Follow the instructions for use of the components.
4Before initial startup and after each use, process the product and acces-
sories appropriately.
4Carry out the processing as described in the instructions for use. The proce-
dure has been validated by the manufacturer.
4If you deviate from this validated procedure, make sure that the processing
procedure is effective.
4After each patient, dispose of the coolant reservoir and replace the hoses.
4Process the product and accessories appropriately before disposal.
2.3 Electrical shock
Use of the product in moist or electrically conductive environments can lead to
electrical shock and injury to patients, users and third parties.
4Use the product in dry environments exclusively.
4Use the product only in environments that are not electrically conductive.
4Protect openings of the product from any ingress of liquids.
4Do not place the product in a trough-like container
4Before each use, check for and ensure the absence of leakage from the
coolant containers and lines.
4If any liquid is detected on the device, disconnect the power cable from the
supply mains right away and do not touch the product.
4Make sure that the surface of the product is absolutely dry before plugging
the power cable back into the socket.
4After servicing, interventions on and repairs of the device and before re-use,
have the service personnel perform safety checks on the device.

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2.4 Technical condition
A damaged device or components can injure patients, users and third parties.
4Use the device and components only if there is no damage on the outside.
4Check the power cable before use.
4Connect only to sockets with a protective contact that meet the respective
national regulations.
4Check to make sure that the device is working properly and is in satisfactory
condition before each use.
4Have parts with sites of breakage or surface changes checked by the Ser-
vice.
4Safety checks may only be performed by trained service personnel.
4If the following defects occur, stop working and have the service personnel
carry out repair work:
▪ Malfunctions
▪ Damage
▪ Irregular running noise
▪ Excessive vibration
▪ Overheating
Careless setup/installation of the product or accessories can cause injury to pa-
tients, users and third parties. Power supplies and/or cords/hoses on the floor
can cause slipping or tripping.
4Power supply and cord/hoses need to be set-up/routed appropriately such
that they are not on the floor.
Failure of the voltage supply or other errors can cause the surgical motor to
come to a standstill possibly leading to injury.
4Make sure that the power supply is working.
2.5 Electromagnetic fields
Electromagnetic fields might interfere with the functions of implanted systems
(such as cardiac pacemakers).
Medical electrical devices are subject to special precautions regarding electro-
magnetic compatibility and must be installed and operated in accordance with
the tables of electromagnetic compatibility.
Also refer to:
13 Information concerning the electromagnetic compatibility according to IEC
60601-1-2,Page64
High-frequency communications devices may interfere with medical electrical
devices.
4Ask patients if they have a cardiac pacemaker or other system implanted
and counsel them about the risks before you start the treatment.
4Comply with the tables of electromagnetic compatibility during installation
and commissioning.
4If the device needs to be used in the immediate vicinity of other equipment,
monitor the device or system for malfunctions.

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2.6 Improper use
Parts that rotate when the pump is running may injure the patient, user and
third parties.
4Do not reach into the pump. Turn off the device when the pump is open.
2.7 Accessories and combination with other equipment
Use of un-authorized accessories on the device or un-authorized modifications
to the device can lead to injury.
4Only use accessories that have been approved for combination with the
product by the manufacturer.
4Do not make any modifications to the device unless these have been ap-
proved by the manufacturer of the product.
Improper use of handpieces can cause injuries.
You need to comply with the following guidelines to ensure the safe use of the
electrically-driven handpieces:
4Comply with the instructions for use of the respective handpiece.
4Check the speed setting each time you turn on the device.
4Comply with the permissible maximum speed and maximum contact pres-
sure of the burs as specified by the bur manufacturer.
4Comply with the servicing instructions for handpieces as specified in the re-
spective instructions for use.
The bluish LED light of the motors can damage the cornea or lens of the eye.
4Do not gaze into the lamp when it is in operation.
4Use adequate shielding for eye protection.
2.8 Qualification of personnel
Application of the product by users lacking appropriate medical training can in-
jure the patient, the user or third parties.
4Make sure that the user has read and comprehends the instructions for use.
4Only employ the device if the user has the appropriate medical training.
4Comply with national and regional regulations.
2.9 Service and repair
Servicing work that is described in the "Servicing" chapter of the present In-
structions for Use can be performed by the operator/user.
Repairs and safety checks may only be performed by trained service personnel.
The following persons are authorized to do this:
▪ Service technicians of KaVo branches after the appropriate product training
▪ Service technicians of KaVo authorized dealers after the appropriate product
training
Comply with the following items during all servicing work:
4Have the service and testing tasks carried out in accordance with the Medi-
cal Device Operation Ordinance.
4After interventions on and repairs of the device and before re-use, have the
service personnel perform a safety check on the device.
4The device should be serviced, cleaned, and stored in a dry location, and
should be disconnected from the power system, according to instructions, if
it is not to be used for extended periods.

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As a result of the use of NON-KaVo original spare parts during the repair, parts
such as covers may become undone and injure the patient, user or other peo-
ple. This may result in aspiration, swallowing of parts and possibly even a risk
of suffocation.
4Only use spare parts that comply with the specification for repair; original
KaVo spare parts comply with the specification.
NOTE
If a repair is done with NON-KaVo original spare parts, this may constitute a
product modification that leads to the loss of CE conformity. In the event of
damage, the responsibility is with the service company or the operator.
The introduction into the market of a modified product, where there is reason-
able suspicion that the safety and health of patients or users may be jeopar-
dized, is prohibited by the German medical device law §4, section 1 no. 1 and
requires a separate conformity check.
2.10 Information on electromagnetic compatibility
NOTICE
Property damage due to unsuitable accessories.
The use of accessories, other components, and cables other than those speci-
fied, with the exception of components and cables sold by KaVo as spare parts
for internal components, can increase emissions or reduce the electromagnetic
immunity of the product.
4Use accessories recommended by KaVo only!
Information on electromagnetic compatibility
NOTE
Based on IEC 60601-1-2 (DIN EN 60601-1-2) concerning the electro-
magnetic compatibility of electrical medical devices, we must draw
your attention to the following points:
Medical electrical devices are subject to special precautions concerning the
electromagnetic compatibility and must be installed and operated in accor-
dance with the KaVo assembly instructions.
High-frequency communications devices may interfere with medical electrical
devices.
KaVo does not guarantee the compliance of accessories, cables, and other
components not supplied by KaVo with the EMC requirements of IEC
60601-1-2 (DIN EN 60601-1-2).
Also refer to:
13 Information concerning the electromagnetic compatibility according to IEC
60601-1-2,Page64

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3 Product description
The EXPERTsurg LUX is a surgical controller in accordance with 21 CFR §
872.4200 (dental handpiece and accessories). The device consists of a surgical
control unit, a foot controller, a surgical motor (separate IFU) + motor cable, an
instruments tray, a holder and a tube set. As a functional principle the soft-
ware-based surgical control unit controls the speed and torque of a dental micro
motor. The unit is equipped with a pump for use of an external coolant hose for
irrigation of the working area. The surgical control unit is operated through the
buttons on the tabletop console or via foot control. The device is designed for
use in combination with the INTRA LUX S600 LED surgical motor (separate
IFU). Straight or contra-angle handpieces with a handpiece connection in accor-
dance with ISO 3964 can be connected. The instrument tray allows the dentist
to deposit the handpieces in a safe position. The holder is intended to be used
for general storage of the bottle. The tube set is needed to deliver the external
coolant from the bottle to the different handpieces. A power cord provides elec-
tric power to the unit. The EXPERTsurg LUX will be delivered with software on
the surgical control unit.
3.1 Intended use
Indications for use:
This KaVo product is intended for use in surgery to expose and dissect oral tis-
sue structures or endodontic treatments (e.g. periodontal gap, gingiva, bone,
jaw, extractions and implantations).
CAUTION
US Federal law restricts this device to sale by or on the order of a
healthcare professional / dentist.
For dental use only.
Proper Use:
NOTE
The EXPERTsurg LUX is approved for use in surgical theaters.
"Intended use" also includes compliance with all of the information in the in-
structions for use and ensuring that all inspection and servicing work is per-
formed as scheduled.
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 indications for use must be applied and followed.
The functional safety and proper condition of the device must be checked be-
fore each use of the device.
The applicable national legal provisions must be heeded during the use of the
device, in particular the following:
▪ Applicable regulations governing the connection and startup of medical de-
vices.
▪ Current occupational safety regulations.
▪ Current accident prevention regulations.
In accordance with these regulations, the user is required to:
▪ only use equipment that is operating properly
▪ adhere to the specified intended use
▪ protect himself or herself, the patient and third parties from danger

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▪ avoid contamination from the product
To guarantee the consistent readiness for use and to preserve the value of the
KaVo product, the recommended maintenance services must be carried out in 2
year intervals.
NOTE
The permitted work is described in the Technician's Instructions available to
the trained service staff.
Operators, equipment managers and users in Germany are obliged to operate
their equipment in accordance with the regulations of the German Medical De-
vices Law. The services encompass all the test tasks required in accordance
with § 6 of the operator ordinance ("MPBetreiberV").
After servicing, interventions, and repairs of the device, the device must be
tested according to IEC 62353 (according to the state of the art) before re-use.

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3.2 Scope of delivery
The scope of delivery of the EXPERTsurg LUX includes the following:
▪ Device EXPERTsurg LUX
▪ Foot control
▪ Surgical motor INTRA LUX S600 LED
▪ Motor cable S600
▪ Handpiece holder
▪ Hose set sterile S600 (5 pcs.)
▪ Bottle holder
▪ Instructions for use EXPERTsurg LUX
▪ Short instructions for use EXPERTsurg LUX
▪ Instructions for use INTRA LUX S600 LED

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3.3 EXPERTsurg LUX
1
2
7
8
3
65
4
9
10
Product reference guide, front view
①Hand-held control panel ⑥Surgical motor
②Bottle holder ⑦Coolant hose
③Hose pump ⑧Handpiece holder
④Hose fixation ⑨Motor cable
⑤Foot control ⑩Symbol of type B applied part

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Rear
Product reference guide, rear view
①Hose pump locking mechanism ⑤Follow instructions for use
②On-button ⑥SD card slot
③Mains plug ⑦Foot control electrical outlet
④Follow the instructions for use

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3.4 Hand-held control panel
①Program step ⑩Minus key, decrease value
②Display of the activity ⑪Back key
③Maximum torque reached ⑫Transmission ratio
④Torque limit ⑬Direction of motor rotation
⑤Speed ⑭Coolant pump settings
⑥Left arrow key ⑮Activation
⑦Plus key, increase value One-touch calibration
⑧Right arrow key ⑯Foot control status indicator /
⑨Motorized device connector Call for service check
Key Function
The back key has two functions:
4Press the back key briefly to proceed to the selec-
tion of program steps.
4Press the back key for a long time in order to ac-
cess the device settings.
4Press the arrow keys to select a parameter.
4Press the Plus key to increase a value.
4Press the Minus key to decrease a value.

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3.5 Foot control
1
3
2
4
①Speed key (grey) ③Program key (grey)
②Pump key (blue) ④Direction of motor rotation key
(yellow)

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3.6 Technical Specifications EXPERTsurg LUX
Width 265mm
Depth 255mm
Height 100mm
Weight Approx 1.9kg
Weight Foot control Approx 1.1kg
Weight motor Approx. 125g
Input voltage 100 – 240V~
Frequency 50/60 Hz
Rated power max. 150W
Speed 300 - 40,000min-1
Max. Torque at motor 5.5Ncm
Pump delivery rate 30 - 110ml/min
Foot control: Protection class IPX8
Foot control: Cable length 2.5m
Length of motor cable 2m
Operating mode
Continuous operation with duty type
30sec. operation/ 9min. pause
NOTE
The maximal motor load is 30 seconds operating time / 9 minutes pause (full
load at maximum speed).
Ambient conditions
WARNING
Inappropriate operating conditions.
Impairment of the electrical safety of the device.
4It is essential to comply with the operating conditions specified in the "Tech-
nical Specifications" chapter.
Temperature +10 oC to +35 oC (50 oF to 95 oF)
Relative humidity 15% to 80%
Air pressure 700hPa to 1060hPa (10psi to 15psi)
Operating altitude up to 3000 m

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3.7 Symbols on product, packaging and rating plate
The product, packaging or rating plates bear the following symbols. The rating
plates of EXPERTsurg LUX and foot control are both affixed on the underside of
the housing.
Accompanying documents
Note: Please note accompanying documents
Follow instructions for use
Please note the electronic instructions for use
HIBC Code
Certification
CE mark for medical devices
VDE mark
MET mark
EAC conformity mark (Eurasian Conformity)
Medical device, labeling of medical devices
Product characteristics
Manufacturer
Manufacturing date
Device type
Serial number
Catalog number
UDI symbol
Type B applied part
Operating mode: continuous operation with intermittent load
Alternating current (AC)

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Supply voltage
Protection class II
Transportation and storage conditions
(temperature range)
Transportation and storage conditions
(air pressure)
Transportation and storage conditions
(humidity)
Protect from moisture
Protect from impact
Transport in upright orientation
Permissible stacking load
Do not dispose of with household waste
3.8 Transport and storage
NOTE
Please keep the packaging in case you need to return the product for servic-
ing or repair.
Transportation and storage conditions
Temperature: -29°C to +50°C (-20°F to +122°F)
Relative humidity: 5% RH to 85% RH absence of condensation
Air pressure: 700 hPa to 1060 hPa (10 psi to 15 psi)
3.8.1 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.