KaVo MASTERsurg LUX Wireless User manual

Instructions for use
MASTERsurg LUX Wireless
REF 1.009.1200

Distributed by:
KaVo Dental GmbH
Bismarckring 39
D-88400 Biberach
Phone [phone]
Fax [phone]
Manufacturer:
Kaltenbach & Voigt GmbH
Bismarckring 39
D-88400 Biberach
www.kavo.com

Table of contents
1 User instructions............................................................................................................................................. 6
1.1 User guide ............................................................................................................................................. 6
1.1.1 Symbols .................................................................................................................................... 6
1.2 Target group .......................................................................................................................................... 6
1.3 Service................................................................................................................................................... 6
1.3.1 Repair Service .......................................................................................................................... 6
1.4 Terms and conditions of warranty.......................................................................................................... 7
1.5 Transportation and storage.................................................................................................................... 7
1.5.1 Currently valid packaging regulations ....................................................................................... 7
1.5.2 Damage in transit...................................................................................................................... 7
1.5.3 Information on the packaging: Storage and transportation ....................................................... 8
2 Safety ............................................................................................................................................................. 10
2.1 Description of safety instructions ........................................................................................................... 10
2.1.1 Warning symbol ........................................................................................................................ 10
2.1.2 Structure ................................................................................................................................... 10
2.1.3 Description of hazard levels...................................................................................................... 10
2.2 Information about electromagnetic compatibility.................................................................................... 10
2.3 Disposal of electronic and electrical devices ......................................................................................... 11
2.4 Safety instructions ................................................................................................................................. 11
3 Description of the product............................................................................................................................... 13
3.1 Intended use .......................................................................................................................................... 13
3.2 MASTERsurg LUX Wireless .................................................................................................................. 14
3.3 Hand-held control panel......................................................................................................................... 16
3.4 Wireless foot control ............................................................................................................................. 17
3.5 Rating plates of MASTERsurg LUX Wireless and wireless foot control ................................................ 17
3.6 Technical Specifications MASTERsurg LUX Wireless .......................................................................... 19
3.7 Scope of delivery ................................................................................................................................... 20
4 Commissioning ............................................................................................................................................... 21
4.1 Unpacking.............................................................................................................................................. 21
4.2 Installing the bottle holder...................................................................................................................... 21
4.3 Getting the wireless foot control ready for operation ............................................................................. 21
4.4 Connecting the surgical motor ............................................................................................................... 24
4.5 Connecting the coolant container and hose set..................................................................................... 24
4.6 Electrical connection.............................................................................................................................. 29
5 Operation........................................................................................................................................................ 31
5.1 Switching the device on ......................................................................................................................... 31
5.2 Device settings ...................................................................................................................................... 31
5.2.1 Setting the language ................................................................................................................. 32
5.2.2 Setting the documentation ........................................................................................................ 32
5.2.3 Setting the LUX brightness ....................................................................................................... 32
5.2.4 Setting the LUX afterglow time ................................................................................................. 33
5.2.5 Setting the operating mode of the foot pedal ............................................................................ 33
5.2.6 Setting the pump key operating mode of the foot control ......................................................... 33
5.2.7 Connect the wireless foot control.............................................................................................. 34
5.2.8 Adjusting the time of day........................................................................................................... 34
Instructions for use MASTERsurg LUX Wireless REF 1.009.1200
Table of contents
3 / 76

5.2.9 Setting the date......................................................................................................................... 35
5.2.10 Setting the LCD brightness ....................................................................................................... 35
5.2.11 Setting the volume .................................................................................................................... 35
5.2.12 Setting the key sound volume................................................................................................... 36
5.2.13 Multi-program mode ................................................................................................................. 36
5.2.14 Exporting settings ..................................................................................................................... 36
5.2.15 Importing settings...................................................................................................................... 36
5.2.16 Factory settings......................................................................................................................... 37
5.2.17 Version...................................................................................................................................... 37
5.3 Surgical Motor INTRA LUX S600 LED .................................................................................................. 37
5.3.1 Attaching the straight or contra-angle handpiece ..................................................................... 38
5.3.2 Removing the straight or contra-angle handpiece .................................................................... 39
5.4 Setting-up multi-program mode ............................................................................................................. 39
5.5 Setting and executing program steps .................................................................................................... 40
5.5.1 Factory settings......................................................................................................................... 40
5.5.2 Exemplary programme step sequences ................................................................................... 42
5.5.3 Selecting the program steps ..................................................................................................... 43
5.5.4 Selecting activities .................................................................................................................... 43
5.5.5 Limiting the program steps........................................................................................................ 44
5.6 Changing default values ........................................................................................................................ 44
5.6.1 Setting the maximum speed ..................................................................................................... 45
5.6.2 Setting the torque limit .............................................................................................................. 45
5.6.3 Setting the coolant flow............................................................................................................. 46
5.6.4 Changing the direction of motor rotation................................................................................... 47
5.6.5 Setting the transmission ratio.................................................................................................... 48
5.7 Rinsing function ..................................................................................................................................... 48
5.7.1 Manual rinsing function ............................................................................................................. 48
5.7.2 Program activity rinsing function ............................................................................................... 49
5.8 Activating the one-touch calibration....................................................................................................... 50
5.9 Implant position...................................................................................................................................... 51
5.10 Documentation....................................................................................................................................... 51
5.11 Wireless foot control ............................................................................................................................. 52
5.11.1 Changing the speed, coolant flow, and direction of motor rotation ........................................... 52
5.11.2 Selecting the program steps ..................................................................................................... 53
5.12 Changing the coolant container ............................................................................................................. 53
6 Decommissioning ........................................................................................................................................... 54
6.1 Disconnecting the electrical connection................................................................................................. 54
6.2 Disposal of the coolant hose.................................................................................................................. 54
6.3 Disconnecting the surgical motor........................................................................................................... 55
6.4 Decommissioning the wireless foot control............................................................................................ 55
6.5 Dismantling the bottle holder ................................................................................................................. 57
7 Reprocessing steps in accordance with DIN EN ISO 17664.......................................................................... 58
7.1 Cleaning................................................................................................................................................. 58
7.1.1 Manual cleaning........................................................................................................................ 58
7.1.2 Machine cleaning ...................................................................................................................... 60
7.2 Disinfection ............................................................................................................................................ 60
7.2.1 Manual disinfection ................................................................................................................... 60
7.2.2 Automated disinfection.............................................................................................................. 61
Instructions for use MASTERsurg LUX Wireless REF 1.009.1200
Table of contents
4 / 76

7.2.3 Drying........................................................................................................................................ 61
7.2.4 Service, inspection and testing after preparation...................................................................... 61
7.3 Packaging .............................................................................................................................................. 61
7.4 Sterilisation ............................................................................................................................................ 62
7.4.1 Storage ..................................................................................................................................... 63
8 Troubleshooting.............................................................................................................................................. 64
9 Run a software update ................................................................................................................................... 67
10 Safety checks ("STK") .................................................................................................................................... 68
11 Accessories .................................................................................................................................................... 69
12 Information about electromagnetic compatibility ............................................................................................ 70
12.1 Guidelines and manufacturer's declaration - electromagnetic emission................................................ 70
12.2 Guidelines and manufacturer's statement - Electromagnetic immunity................................................. 70
12.3 Guidelines and manufacturer's statement - Electromagnetic immunity................................................. 71
12.4 Recommended safe distances between portable and mobile HF telecommunications equipment and
the MASTERsurg LUX Wireless ............................................................................................................ 72
Instructions for use MASTERsurg LUX Wireless REF 1.009.1200
Table of contents
5 / 76

Instructions for use MASTERsurg LUX Wireless REF 1.009.1200
1 User instructions | 1.1 User guide
6 / 76
1 User instructions
1.1 User guide
1.1.1 Symbols
Refer to the chapter on Safety/Warning symbol
Important information for users and service technicians
Thermodisinfectable
Sterilisable up to 135 oC
CE mark (European Community). A product bearing this mark meets the re-
quirements of the pertinent EC directives, i.e. the standards applicable in
Europe.
1.2 Target group
This document is for dentists and dental office staff.
1.3 Service
Please direct all questions regarding the product, service, and maintenance to the fol-
lowing addresses.
Please refer to the serial number of the product in all inquiries!
Service-Hotline:
[phone]
[email protected]
For further information, please visit: www.kavo.com
1.3.1 Repair Service
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.
For scheduling or if you have any questions, please call:
KaVo Repair Service
[phone]
[email protected]
KaVo Dental GmbH
Repairs
Bahnhofstr. 18
88447 Warthausen

Instructions for use MASTERsurg LUX Wireless REF 1.009.1200
1 User instructions | 1.4 Terms and conditions of warranty
1.4 Terms and conditions of warranty
KaVo provides the final customer with a warranty that the product cited in the han-
dover 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 compens-
ation, 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 servicing, non-compliance with operating, servicing or connection
instructions, calcification or corrosion, contaminated air or water supplies or chemical
or electrical factors deemed abnormal or impermissible in accordance with factory
specifications.
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.
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.
1.5 Transportation and storage
1.5.1 Currently valid packaging regulations
Note
Only valid for the Federal Republic of Germany.
Dispose of and recycle the sales packaging appropriately in accordance with current
packaging regulations, employing waste management or recycling companies. Com-
ply with the comprehensive return system. KaVo has had its sales packaging licensed
for this purpose. Please comply with the regional public waste-disposal system.
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 re-
ceipt. 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. Consult with KaVo first, before returning a damaged product.
7. Send the signed delivery receipt to KaVo.
7 / 76

Instructions for use MASTERsurg LUX Wireless REF 1.009.1200
1 User instructions | 1.5 Transportation and storage
8 / 76
If the product is damaged but there was no discernable damage to the packaging on
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-mentioned oblig-
ations will mean that the damage will be considered to have arisen following deliv-
ery (in accordance with the General German Freight Forwarders´ Terms and Condi-
tions, Art. 28).
Outside Germany
Note
KaVo shall not be held liable for damage arising from transportation.
The shipment must be checked on arrival.
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 re-
ceipt. 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 on
delivery, proceed as follows:
1. Report any damage to the shipping company either immediately or no later than 7
days after delivery.
2. Leave the product and packaging in the condition in which you received it.
3. Do not use a damaged product.
Note
If the recipient fails to comply with any of the above-mentioned obligations, 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!

Instructions for use MASTERsurg LUX Wireless REF 1.009.1200
1 User instructions | 1.5 Transportation and storage
Permissible stacking load
Temperature range
Humidity
Air pressure
9 / 76

Instructions for use MASTERsurg LUX Wireless REF 1.009.1200
2 Safety | 2.1 Description of safety instructions
10 / 76
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 hazard.
This section describes potential consequences of non-compliance.
▶ The optional step includes necessary measures for hazard prevention.
2.1.3 Description of hazard levels
Safety instructions distinguishing between three hazard levels are used in this docu-
ment to prevent personal and property damage.
CAUTION
CAUTION
indicates a hazardous situation that can cause damage to property or mild to moder-
ate injuries.
WARNING
WARNING
indicates a hazardous situation that can lead to serious or fatal injury.
DANGER
DANGER
indicates a maximal hazard due to a situation that can directly cause death or fatal in-
jury.
2.2 Information about electromagnetic compatibility
Note
Based on IEC 60601-1-2 (DIN EN 60601-1-2) concerning the electromagnetic com-
patibility of electrical medical devices, we must draw your attention to the following
points:
• Medical electrical devices are subject to special precautions concerning the elec-
tromagnetic compatibility and must be installed and operated in accordance with the
KaVo assembly instructions.
• High-frequency communications devices may interfere with electrical medical
devices.
See also:
212 Information about electromagnetic compatibility, Page 70

Instructions for use MASTERsurg LUX Wireless REF 1.009.1200
2 Safety | 2.3 Disposal of electronic and electrical devices
Note
KaVo cannot guarantee the compliance of accessories, cables, and other compon-
ents not supplied by KaVo with the EMC requirements of IEC 60601-1-2 (DIN EN
60601-1-2).
2.3 Disposal of electronic and electrical devices
Note
According to EC directive 2012/19 concerning used electrical and electronic
devices, this product is subject to the cited directive and must be disposed of ac-
cordingly within Europe.
For more information, please visit www.kavo.com or contact your specialised dental
supplier.
For final disposal:
In Germany
To return an electrical device, you need to proceed as follows:
1. On the homepage www.enretec.de of enretec GmbH, you can download a form for
a disposal order under the menu item eom. Download the disposal order or com-
plete it as an online order.
2. Enter the corresponding information to complete the order, and submit it as an on-
line order or by fax [phone] to enretec GmbH.
The following contact options are also available for questions and for initiating a
disposal order:
Phone: [phone]
Email: [email protected] and
Postal address: enretec GmbH, Geschäftsbereich eomRECYCLING®
Kanalstraße 17
D-16727 Velten
3. A unit that is not permanently installed will be picked up at the office.
A permanently installed unit will be picked up at the curb at your address on the
agreed date.
The owner or user of the device will have to bear the cost of disassembly, trans-
portation and packaging.
International
For country-specific information on disposal, contact your dental supplier.
2.4 Safety instructions
WARNING
Application of un-authorised accessories or un-authorised modifications of the
product.
Accessories that have not been approved and/or inadmissible modifications of the
product could lead to hazards and/or personal injury or property damage.
▶ Only use accessories that have been approved for combination with the product
by the manufacturer or are equipped with standardised interfaces (e. g. MULTIflex
couplings, INTRAmatic).
▶ Do not make any modifications to the device unless these have been approved by
the manufacturer of the product.
11 / 76

Instructions for use MASTERsurg LUX Wireless REF 1.009.1200
2 Safety | 2.4 Safety instructions
12 / 76
CAUTION
Electrical sparks in the product.
Explosion and/or fire.
▶ Do not use product in areas subject to an explosion hazard.
▶ Do not operate the product in an oxygen-enriched atmosphere.
CAUTION
Damaged mains cable / missing protective conductor.
Electrical shock.
▶ Check the mains cable before use. The socket outlet must have a protective con-
tact and meet the respective national guidelines.
CAUTION
Damage by liquids.
Faults on electrical components.
▶ Protect openings of the product from any ingress of liquids.
CAUTION
Inadvertent penetration of liquids.
Electrical shock.
▶ Do not place the product in a tub-like container.
▶ Check the coolant containers and lines for absence of leakage. If any liquid is de-
tected on the device, do not touch the device and disconnect the device from the
mains supply without delay. Make sure that the surface of the device is com-
pletely dry before plugging the main plug back in the socket.
CAUTION
Rotating parts while the pump is operating
Injuries
▶ Do not stick anything in the pump. Turn off the device when the pump is open.
CAUTION
Risks from electromagnetic fields.
Electromagnetic fields might interfere with the functions of implanted systems (such
as pacemakers).
▶ Ask patients if they have a cardiac pacemaker or other system implanted before
you start the treatment!
CAUTION
Impact of power failure.
Failure of the voltage supply or other errors can cause the surgical motor to come to a
standstill.
▶ Make sure that the power supply is working.

Instructions for use MASTERsurg LUX Wireless REF 1.009.1200
3 Description of the product | 3.1 Intended use
3 Description of the product
3.1 Intended use
Note
The MASTERsurg LUX Wireless is approved for use in surgical theatres.
This KaVo product is intended only for use in the field of dentistry, for surgery to ex-
pose and dissect oral tissue structures or endodontic treatments (e.g. periodontal gap,
gingiva, bone, jaw, extractions, implantations) and must be used by expert medical
staff only. Any other type of use is not permitted.
"Proper use" includes compliance with all information in the Instructions for Use and
ensuring that all inspections 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 must be applied and followed.
The user must ensure that the unit works properly and is in satisfactory condition be-
fore each use.
The applicable national legal regulations must be observed during the use of the
device, in particular the following:
▪ Applicable regulations governing the connection and start-up of medical devices.
▪ Current occupational safety regulations.
▪ Current accident prevention regulations.
It is a responsibility of the user:
▪ to only use equipment that is operating correctly,
▪ to protect him or herself, the patient and third parties from hazards, and
▪ to prevent 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 inter-
vals.
The following persons are authorised to repair and service the KaVo product:
▪ Technicians of KaVo branch offices after appropriate product training.
▪ Specifically KaVo-trained technicians of KaVo franchised dealers.
Note
The permitted work is described in the Technician's Instructions available to the
trained service staff.
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 med-
ical devices operator ordinance (Medizinprodukte-Betreiberverordnung, MPBetreibV).
After servicing, interventions, and repairs of the device, the device must be tested ac-
cording to IEC 62353 (according to the state of the art) before re-use.
13 / 76

Instructions for use MASTERsurg LUX Wireless REF 1.009.1200
3 Description of the product | 3.2 MASTERsurg LUX Wireless
14 / 76
Note
The product must be cleaned and serviced according to instructions if it is not to be
used for an extended period of time.
Note
Any waste which is generated must be recycled or disposed of in strict compliance
with all applicable national regulations in a manner which is safe both for people
and the environment.
If you have any questions regarding proper disposal of the KaVo product, please
contact the KaVo branch.
Note
A recycling pass can be downloaded from www.kavo.com.
3.2 MASTERsurg LUX Wireless
1
2
7
8
3
65
4
9
10
① Hand-held control panel ② Bottle holder
③ Hose pump ④ Hose fixation
⑤ Wireless foot control ⑥ Surgical motor
⑦ Coolant hose ⑧ Handpiece tray
⑨ Motor cable ⑩ Symbol of type B applied part

Instructions for use MASTERsurg LUX Wireless REF 1.009.1200
3 Description of the product | 3.2 MASTERsurg LUX Wireless
Rear
3
2
1
54 6
① Hose pump locking mechanism ② On-button
③ Power plug ④ Please note the instructions for use
⑤ Follow the instructions for use ⑥ SD card slot
15 / 76

Instructions for use MASTERsurg LUX Wireless REF 1.009.1200
3 Description of the product | 3.3 Hand-held control panel
16 / 76
3.3 Hand-held control panel
3
2
14 5
678910 11
① Program step ② Display of the activity
③ Maximal torque reached ④ Torque limit
⑤ Speed ⑥ Wireless foot control status indicator /
input implant position
⑦ Activation of one-touch calibration ⑧ Coolant pump settings
⑨ Direction of motor rotation ⑩ Transmission ratio
⑪ Back key
The back key has two functions. Pressing the back key briefly returns you to the pre-
vious step. Pressing the back key long opens the device settings.

Instructions for use MASTERsurg LUX Wireless REF 1.009.1200
3 Description of the product | 3.4 Wireless foot control
3.4 Wireless foot control
1
3
2
4
① Speed key (grey) ② Pump key (blue)
③ Programme key (grey) ④ Direction of motor rotation key (yellow)
3.5 Rating plates of MASTERsurg LUX Wireless and wireless foot
control
The rating plates of MASTERsurg LUX Wireless and wireless foot control are affixed
on the underside of the housing and include the following symbols:
CE mark
VDE mark
CSA mark
Classification, type B
Please note the instructions for use
Please note the electronic instructions for use
17 / 76

Instructions for use MASTERsurg LUX Wireless REF 1.009.1200
3 Description of the product | 3.5 Rating plates of MASTERsurg LUX Wireless and wireless foot control
18 / 76
Follow the instructions for use
Operating mode: continuous operation with intermittent load
Alternating current (AC)
Supply voltage
Protection class II
Manufacturer
YYYY = Year manufactured
XXXXXXX = Serial number
Material number
Type: Device type
For disposal information, see Intended use
GOST R certification
HIBC Code
Product includes HF emitter

Instructions for use MASTERsurg LUX Wireless REF 1.009.1200
3 Description of the product | 3.6 Technical Specifications MASTERsurg LUX Wireless
3.6 Technical Specifications MASTERsurg LUX Wireless
Width 265mm
Depth 255mm
Height 100mm
Weight approx. 2.0 kg
Weight of wireless foot control approx. 1.1 kg
Weight of motor approx. 125 g
Input voltage 100 - 240 V ~
Input frequency 50/60 Hz
Rated power max. 150 W
Speed 300 – 40,000 rpm
Max. torque on the motor 5.5 Ncm
Pump delivery rate 30 - 110 ml/min
Wireless foot control: Class of protection IPX8
Wireless foot control: Emitted power max. 3 dBm (e.i.r.p.)
Wireless foot control: Frequency band ISM 2.4 GHz
Length of motor cable 6.5 ft (2 m)
Operating mode
Continuous operation with intermittent
load
30 sec. of operation/ 9 min. pause
Note
The maximal motor load is 30 seconds operating time / 9 minutes pause (full load at
maximal speed).
Transportation and storage conditions
Ambient temperature -20 ℃ - +50 ℃
Relative humidity 5% - 95%
Air pressure 700 hPa - 1,060 hPa
Operating environment
WARNING
Inappropriate operating conditions.
Impairment of the electrical safety of the device.
▶ It is essential to comply with the operating conditions specified in the "Technical
Specifications" chapter.
19 / 76

Instructions for use MASTERsurg LUX Wireless REF 1.009.1200
3 Description of the product | 3.7 Scope of delivery
20 / 76
Ambient temperature +10 ℃ - +35 ℃
Relative humidity 15% - 80%
Air pressure 700 hPa - 1,060 hPa
Max. elevation for operation up to 3,000 m
3.7 Scope of delivery
The scope of delivery of the MASTERsurg LUX Wireless includes the following:
▪ MASTERsurg LUX Wireless unit
▪ Wireless foot control
▪ Surgical motor INTRA LUX S600 LED
▪ Motor cable S600
▪ Instrument tray
▪ Hose set sterile S600 (5 units)
▪ Bottle holder
▪ Batteries, alkaline type AA/ LR6 (3 pcs.)
▪ SD memory card (with sample programme)
▪ Instructions for use MASTERsurg LUX Wireless
▪ Brief instructions for use MASTERsurg LUX Wireless
▪ Instructions for use INTRA LUX S600 LED