KaVo MASTERsurg LUX Wireless, 1.009.1200 Instructions For Use 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

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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

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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

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Instructions for use MASTERsurg LUX Wireless REF 1.009.1200

1 User instructions | 1.1 User guide

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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 re­quirements 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 fol­lowing addresses.
Please refer to the serial number of the product in all inquiries!
Service-Hotline:
[phone]
[e-mail]
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]
[e-mail]
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 han­dover 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 war­ranty 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 compens­ation, 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 colour­fastness 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. Com­ply 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 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. Consult with KaVo first, before returning a damaged product.

7. Send the signed delivery receipt to KaVo.

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Instructions for use MASTERsurg LUX Wireless REF 1.009.1200

1 User instructions | 1.5 Transportation and storage

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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 oblig­ations will mean that the damage will be considered to have arisen following deliv­ery (in accordance with the General German Freight Forwarders´ Terms and Condi­tions, 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 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 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

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Instructions for use MASTERsurg LUX Wireless REF 1.009.1200

2 Safety | 2.1 Description of safety instructions

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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 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 docu­ment 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 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 accordance with the
KaVo assembly instructions.

• High-frequency communications devices may interfere with electrical medical
devices.

See also:

2 12 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 compon­ents 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 ac­cordingly 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 com­plete it as an online order.

2. Enter the corresponding information to complete the order, and submit it as an on­line 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: [e-mail] 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, trans­portation 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.

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2 Safety | 2.4 Safety instructions

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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 com­pletely 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 ex­pose 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 be­fore 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 inter­vals.

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 med­ical devices operator ordinance (Medizinprodukte-Betreiberverordnung, MPBetreibV).

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 Description of the product | 3.2 MASTERsurg LUX Wireless

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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

6

5

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

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3 Description of the product | 3.3 Hand-held control panel

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3.3 Hand-held control panel

3

2

1

4 5

6

7

8

9

10

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 pre­vious 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

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3 Description of the product | 3.5 Rating plates of MASTERsurg LUX Wireless and wireless foot control

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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.

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3 Description of the product | 3.7 Scope of delivery

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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

Instructions for use MASTERsurg LUX Wireless REF 1.009.1200

4 Commissioning | 4.1 Unpacking

4 Commissioning

4.1 Unpacking

Note

You need to keep the cardboard box and all packaging materials to be able to
safely ship the unit in the future.

▶ Open the cardboard box.
▶ Remove the hose boxes.
▶ Take out the wireless foot control and additional equipment.
▶ To take out the unit, pull it vertically upward and place it on a level surface.

4.2 Installing the bottle holder

▶ Slide the bottle holder ① in the guide on the underside of the unit.

ð The bottle holder ① snaps into place audibly and is then affixed.

4.3 Getting the wireless foot control ready for operation

1

2

▶ On the underside of the wireless foot control, press down the snap-in lug ① of the

speed button ② and take the speed button ② off the wireless foot control.

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4 Commissioning | 4.3 Getting the wireless foot control ready for operation

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1

▶ Pull the button bar ① including the pump button, program button, and motor direc-

tion button slightly upwards and take it off the wireless foot control.
▶ To open the lid, turn it to the left and take it off.
▶ Insert 3 batteries, alkaline type AA/ LR6.

▶ Place the lid on the unit (arrow points at "Open" symbol) and close it by turning it

clockwise (arrow points at "Closed" symbol).

1

2

222

3

Instructions for use MASTERsurg LUX Wireless REF 1.009.1200

4 Commissioning | 4.3 Getting the wireless foot control ready for operation

▶ Plug the button bar ① onto the wireless foot control ② and press it on lightly until

the button bar ① snaps into place ③.

1

2

333

333

4

▶ Plug the speed button ① onto the wireless foot control and press it on lightly until

the snap-in lug ② snaps in. Make sure that the foot pedal springs are situated in

the recesses of the housing ③.

▶ Slide the bracket into the designated recesses.

The wireless foot control is now ready for operation and can be used. The initial con­nection is done at the factory.

Note

Stand-by mode
The wireless foot control does not need to be switched on and off. It switches into

stand-by mode automatically after a certain period of rest or once the MASTERsurg
LUX Wireless is switched off. To start the wireless foot control, briefly press the
pedal once.

Note

If the wireless foot control is not connected or if it is in stand-by mode, a yellow
warning symbol of the wireless foot control is shown on the display of the MASTER­surg LUX Wireless.

▶ To solve the problem:

See also:

2 5.2.7 Connect the wireless foot control, Page 34

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4 Commissioning | 4.4 Connecting the surgical motor

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4.4 Connecting the surgical motor

Note

The delivered parts are not sterile (except for the coolant hose). Before the first
treatment of a patient, the surgical motor, motor cable, and the handpiece tray need
to be reprocessed.

See also:

2 7 Reprocessing steps in accordance with DIN EN ISO 17664, Page 58

1

23

4

① Motor coupling ② Surgical motor
③ Handpiece tray ④ Plug of motor cable

▶ Plug the surgical motor ② into the motor coupling ① and secure it with a union

nut. Please note the separate instructions for use of the motor.
▶ Place the surgical motor on the handpiece tray ③.
▶ Insert the plug of the motor cable ④ into the connector on the device, align the

marker points, and insert the plug until it snaps into place.

4.5 Connecting the coolant container and hose set

CAUTION

Running, open hose pump.
Risk of injury.

▶ Turn off the device before opening the hose pump.

Instructions for use MASTERsurg LUX Wireless REF 1.009.1200

4 Commissioning | 4.5 Connecting the coolant container and hose set

CAUTION

Danger of tipping due to the coolant containers being too heavy.
Malfunctions.

▶ Use coolant containers with a maximal volume of 1 litre only.
▶ Check the stability.

Note

The coolant must be selected to suit the planned application. The flow rate of the
coolant is dependent on the instrument used. The user must set an adequate flow
of coolant and check this.

Note

The hose set sterile S 600 (10 pcs.) (

Mat. no. 1.009.8757

) must be changed after

each application.

Note

Check the integrity of the hose set before use. If product or packaging are dam­aged, the product needs to be discarded.

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4 Commissioning | 4.5 Connecting the coolant container and hose set

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ca.10 mm

① Coolant hose ② Clips
③ Hose fixation ④ Lock
⑤ Pump hose ⑥ Insertion needle
⑦ Hose clamp

① Coolant hose ② Clip
③ Hose fixation ④ Lock
⑥ Insertion needle ⑦ Hose clamp

Instructions for use MASTERsurg LUX Wireless REF 1.009.1200

4 Commissioning | 4.5 Connecting the coolant container and hose set

▶ Close the hose clamp ⑦ of the hose set.
▶ Attach the coolant hose ① to the straight or contra-angle handpiece.
▶ Place the coolant hose ① tightly, without loops or kinks, against the outside of the

motor cable and attach it in regular intervals using the enclosed clips ②.
▶ Plug the hose fixation ③ into the opening of the device with the blue border until

the hose fixation ③ snaps in.

Note

The unit recognises the hose fixation. If the unit fails to recognise the hose fixation
or if it is not plugged in, the coolant supply symbol is shown with a yellow back­ground.

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Instructions for use MASTERsurg LUX Wireless REF 1.009.1200

4 Commissioning | 4.5 Connecting the coolant container and hose set

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ca.10 mm

▶ Open the lock ④ and insert the pump hose ⑤.
▶ Close the lock ④.

Note

Make sure to place the pump hose in the pump appropriately such that the pump
hose does not get clamped or pinched by the lock. Route all hoses relaxed and
without tension.

Instructions for use MASTERsurg LUX Wireless REF 1.009.1200

4 Commissioning | 4.6 Electrical connection

▶ Stick the puncture needle ⑥ into the coolant container and hook-in the coolant

container on the bottle holder.
▶ Check the sealing and firm seating of the puncture needle ⑥. Prevent fluid from

leaking above the device.
▶ If you use a glass bottle, open the ventilation on the puncture needle ⑥.
▶ If you use a bag, keep the ventilation on the puncture needle ⑥ closed.
▶ Open the hose clamp ⑦ before startup.

Note

Using a new hose, it may take up to approx. 10 seconds for the coolant to exit on
the handpiece, depending on the feed rate.

4.6 Electrical connection

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.

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4 Commissioning | 4.6 Electrical connection

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Note

The unit must be set-up appropriately such that the mains plug and the electrical
outlet are easily accessible.

Note

The protective earth conductor is used as functional earthing (FE) rather than as
protective earthing (PE).

▶ Plug the mains cable first into the mains socket on the device and then the other

end of the mains cable into the electrical outlet of the supply network.

Instructions for use MASTERsurg LUX Wireless REF 1.009.1200

5 Operation | 5.1 Switching the device on

5 Operation

5.1 Switching the device on

▶ Turn the device on.

ð The device runs a self test.

Note

Unless the unit is monitored, KaVo recommends turning it off for safety and energy­saving reasons.

Note

Auto-Off function
After 10 minutes of inactivity, the light on the handpiece, the pump and the motor on

the unit are turned off.

5.2 Device settings

The following device settings can be made or displayed:

▪ Setting the language

▪ Setting the documentation

▪ Setting the LUX brightness

▪ Setting the LUX afterglow time

▪ Setting the operating mode of the foot pedal

▪ Setting the pump key operating mode of the foot control

▪ Connect the wireless foot control

▪ Adjusting the clock time

▪ Setting the date

▪ Setting the LCD brightness

▪ Setting the volume

▪ Setting the key sound volume

▪ Multi-programme mode

▪ Exporting settings

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5 Operation | 5.2 Device settings

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▪ Importing settings

▪ Factory settings

▪ Version

▶ Press the back key for a long time in order to access the device settings.

5.2.1 Setting the language

▶ Press the plus and minus keys to change the language.

5.2.2 Setting the documentation

Three modes are available:

▪ Implant: Documentation during implant insertion

▪ Permanent: Documentation of entire treatment process on SD card

▪ Off: Documentation disabled

▶ Touch the plus and minus keys to set the documentation mode.

5.2.3 Setting the LUX brightness

The LUX brightness determines the brightness of the LEDs on the handpiece. The
brightness can be set in 4 steps ranging from off to maximal brightness.

▶ Press the plus and minus keys to change the LUX brightness.

Instructions for use MASTERsurg LUX Wireless REF 1.009.1200

5 Operation | 5.2 Device settings

5.2.4 Setting the LUX afterglow time

The LUX afterglow time determines how long the handpiece LEDs afterglow after
each motor stop. The afterglow time can be set from 0 to 10 seconds.

▶ Press the plus and minus keys to change the LUX afterglow.

5.2.5 Setting the operating mode of the foot pedal

The motor can be triggered in either of two operating modes:

The motor starts at full speed when the foot pedal is actuated.

The motor speed can be adjusted continuously up to the maximal level using the foot
pedal

▶ Touch the symbol to change the operating mode of the foot pedal.

5.2.6 Setting the pump key operating mode of the foot control

The pump can be triggered in either of two operating modes:

Actuating the pump key switches the coolant flow on or off.

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5 Operation | 5.2 Device settings

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Actuating the pump key gradually increases the coolant flow up to its maximum value.

▶ Touch the symbol to change the operating mode of the pump key on the foot con-

trol.

5.2.7 Connect the wireless foot control

The wireless foot control can control all functions of the surgical unit to which it is con­nected.

Note

In order to ensure that only a combination of control unit and wireless foot control
communicate, these need to be connected.

The wireless foot control can be connected in three steps:

1. Touch the symbol to start the connection process.

2. Press and hold down the speed button of the wireless foot control for at least 1
second.

3. Release the speed button and then press both the left and the right button of the
wireless foot control concurrently until the confirmation of connection "Successfully
connected to wireless foot control" is displayed. This process can take up to 15
seconds.

▶ Press the back key to return to the selection of device settings.

5.2.8 Adjusting the time of day

The time of day can be set as hours, minutes and seconds:

Instructions for use MASTERsurg LUX Wireless REF 1.009.1200

5 Operation | 5.2 Device settings

▶ Press the plus and minus keys to change the time of day.

5.2.9 Setting the date

The date can be set as day, month and year:

▶ Press the plus and minus keys to change the date.

5.2.10 Setting the LCD brightness

The LCD brightness determines the brightness of the display. The brightness can be
set in 3 steps ranging from dark to maximal brightness.

▶ Press the plus and minus keys to change the LCD brightness.

5.2.11 Setting the volume

The volume level determines the volume of signal sounds. The volume can be set in 3
steps ranging from quiet to maximal volume. The volume cannot be turned off for
safety reasons.

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5 Operation | 5.2 Device settings

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▶ Press the plus and minus keys to change the volume.

5.2.12 Setting the key sound volume

The key sound determines the volume of the sound made when a key is pressed. The
volume can be set in three steps or switched off.

▶ Press the plus and minus keys to change the volume of button sounds.

5.2.13 Multi-program mode

▪ One program: One program with up to 4 to 10 program steps and/or activities is

available. After start-up, you can start immediately with the first step of treatment.

▪ Multiple programs: After start-up, an overview of the 10 programs is displayed. For

each program, up to 4 to 10 program steps and/or activities are available.

5.2.14 Exporting settings

The export of settings allows the user to export all device settings in a
<SURG_MA.SET> file to the SD card. KaVo recommends exporting the settings as
soon as the individual basic settings have been made.

5.2.15 Importing settings

The import of settings allows the user to import all device settings in a
<SURG_MA.SET> file from the SD card. This allows a defined status to be restored,
e.g. if settings were changed or deleted inadvertently.

Instructions for use MASTERsurg LUX Wireless REF 1.009.1200

5 Operation | 5.3 Surgical Motor INTRA LUX S600 LED

5.2.16 Factory settings

Factory settings can be used to re-set the unit to its condition at the time of delivery.
All program steps and device settings are re-set to their default values.

▶ Touch the symbol to restore the factory settings.

In the window, you will be asked whether or not you wish to carry out the action.

▶ Touch "Yes" to carry out the action.
▶ Press "No" or the back key to discontinue the action.

5.2.17 Version

Display of software version (presently: 01.10)

▶ Press the back key for a long time in order to exit from the device settings.

5.3 Surgical Motor INTRA LUX S600 LED

Note

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

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5 Operation | 5.3 Surgical Motor INTRA LUX S600 LED

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See also:

2 Instructions for use INTRA LUX S600 LED

5.3.1 Attaching the straight or contra-angle handpiece

CAUTION

Damage from changing the straight and contra-angle handpieces during operation.
Wear to the catch on the straight and contra-angle handpiece and motor.
Unbalanced motor axis.

▶ Change the straight and contra-angle handpieces only when the motor is not run-

ning.

Note

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

All straight and contra-angle handpieces with INTRAmatic connection ISO 3964 can
be attached.

▶ Place the KaVo handpiece on the motor, lightly press it against the motor while

turning it slightly in the direction of the arrow until the guide stud can be heard to
lock into place.

▶ Pull on the KaVo handpiece to make sure that it is securely attached to the motor.

1

2

3

▶ Route the coolant hose ③ from the unit along the motor cable (clips) and connect

it to the straight or contra-angle handpiece ①. Place the coolant hose ③ into the
holding ring ② for this purpose.

Instructions for use MASTERsurg LUX Wireless REF 1.009.1200

5 Operation | 5.4 Setting-up multi-program mode

5.3.2 Removing the straight or contra-angle handpiece

CAUTION

Damage from changing the straight and contra-angle handpieces during operation.
Wear to the catch on the straight and contra-angle handpiece and motor.
Unbalanced motor axis.

▶ Change the straight and contra-angle handpieces only when the motor is not run-

ning.

▶ Pull the coolant hose off the straight or contra-angle handpiece.
▶ Twist the straight or contra-angle handpiece slightly to pull it off.

5.4 Setting-up multi-program mode

A total of 10 programs are available to the user. These can be assigned, e.g., to vari­ous users or implant systems. Each program includes 4 to 10 program steps and/or
activities.

After start-up, an overview of the 10 programs is displayed.

▶ Changing page. Programs 1 to 5 on page 1; programs 6 to 10 on page 2

▶ Changing the name of the selected program.

▶ Deleting a program and/or resetting program settings and name to factory set-

tings.

▶ Run selected program.

Multi-program mode can be disabled in the device settings here.

Note

In One-program mode, changes to settings become effective in program 1 (topmost
program on page 1).

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Instructions for use MASTERsurg LUX Wireless REF 1.009.1200

5 Operation | 5.5 Setting and executing program steps

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5.5 Setting and executing program steps

The MASTERsurg LUX Wireless is based on program steps and associated activities
and can be operated intuitively using the graphical user interface.

1

2

Program step 1: Marking

The current program step is shown on the display as number ① and the correspond­ing activity is shown as symbol ②. Each program step can be assigned to any activity
by selecting the corresponding symbol.
Visualising the activity is an easy means for checking if the activity set on the device is
the same as the current treatment step. Maloperation can thus be largely prevented.

Default values have been set at the factory for the parameters, speeds, torques, trans­mission ratios and coolant flow rate for every activity according to application. The
parameters can be changed only within a reasonable range for the specific activity. In
the activity, "Free application", all available values can be set. The table below lists the
ranges of values and factory settings.
A treatment sequence can consist of 4 to 10 program steps and/or activities. The
treatment sequence can be designed individually through any arrangement of the
activities. During the sequence, the wireless foot control is used for navigation such
that the device does not have to be touched again during the intervention.
Changed values are saved automatically and are then available for the next use.

5.5.1 Factory settings

The following program steps are pre-set at the factory:

Programme
step

Icon Activity Speed [rpm] Torque [Ncm] Transmission

ratio

Coolant flow

1 Marking 200 – 2,000

500 (D)

5 – 20
10 (D)

16:1
27:1
20:1 (D)

0 – 4
2 (D)

2 Pilot drilling 200 – 2,000

500 (D)

5 – 20
10 (D)

16:1
27:1
20:1 (D)

0 – 4
2 (D)

Instructions for use MASTERsurg LUX Wireless REF 1.009.1200

5 Operation | 5.5 Setting and executing program steps

Programme
step

Icon Activity Speed [rpm] Torque [Ncm] Transmission

ratio

Coolant flow

3 Template

drilling

200 – 2,000
500 (D)

5 – 20
10 (D)

16:1
27:1
20:1 (D)

0 – 4
2 (D)

4 Tapping 15 – 50

20 (D)

5 – 80
25 (D)

16:1
27:1
20:1 (D)

0 – 4
2 (D)

5 Placing im-

plant

15 – 50
20 (D)

5 – 80
25 (D)

16:1
27:1
20:1 (D)

0 – 4
0 (D)

6 Setting a clos-

ure cap

15 – 50
20 (D)

5 – 15
8 (D)

16:1
27:1
20:1 (D)

0 – 4
0 (D)

7 Free use 300 – 40,000

40,000 (D)

0.15 – 5.5
3 (D)

1:1 0 – 4

2 (D)

20 – 2,000 5 – 80 16:1

15 – 2,000 5 – 80 20:1

15 – 1,200 5 – 80 27:1

8 Rinsing func-

tion

– – – –

9 Treatment

completed
(can be set
from pro­gramme step

4)

– – – –

(D) = factory setting (default setup)

Note

The listed indications are only examples. In order to prevent risks, it is essential to
comply with the manufacturer recommendations concerning implants, handpieces,
and tools.

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5 Operation | 5.5 Setting and executing program steps

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5.5.2 Exemplary programme step sequences

Example 1: Factory setting

Step 1 2 3 4 5 6 7 8

Activity Marking Pilot drilling Template

drilling

Thread cut­ting

Placing im­plant

Setting
closure cap

Free use Treatment

completed
(can be set
from pro­gram step

4)

Symbol

Example 2: Program steps that do not include the activity, "Cut thread",
and include the "Rinsing function" activity

Step 1 2 3 5 4 5 7

Activity Marking Pilot drilling Template

drilling

Rinsing func­tion

Placing im­plant

Setting clos­ure cap

Treatment
completed
(can be set
from pro­gram step 4)

Symbol

Example 3: Activity "Free use" as step 1, screw implant in manually

Step 1 2 3 4 5

Activity Free use Marking Pilot drilling Template drilling Treatment com-

pleted (can be
set from program
step 4)

Symbol

Instructions for use MASTERsurg LUX Wireless REF 1.009.1200

5 Operation | 5.5 Setting and executing program steps

5.5.3 Selecting the program steps

▶ Select step by touching the program step display.

The program step is saved automatically.

The program steps can be selected during the treatment using the program key of the
wireless foot control. After the last program step follows the first step again. Press the
program key long to select the previous program step.

See also:

2 5.11 Wireless foot control, Page 52

5.5.4 Selecting activities

▶ Touch the symbol. This opens a window that shows all activities.

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5 Operation | 5.6 Changing default values

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▶ Select the desired activity.

The activity is saved automatically.

5.5.5 Limiting the program steps

The number of program steps can be limited. Program steps that are not needed are
deleted from the display.

2

1

3

4

▶ Touch the upper or lower black program step on the display to select program

step ②, which terminates the treatment (can be set from program step 4).

▶ Touch the activity display.
▶ Select the flag symbol.

The settings are saved automatically and the treatment is terminated with the selected
program step.
Navigating through the program steps with the wireless foot control, the step with the
flag symbol is skipped.

Undo the limitation of program steps

▶ Select the program step with the flag symbol and assign different activity.

5.6 Changing default values

The default values set at the factory can be changed within a given range. If the selec­ted activity is Free use, the values can be set freely.

The following values can be changed:

▪ Maximal speed

▪ Torque limit

▪ Coolant flow

▪ Direction of motor rotation

▪ Transmission ratio

Instructions for use MASTERsurg LUX Wireless REF 1.009.1200

5 Operation | 5.6 Changing default values

▶ Select the desired value by touching it.
▶ To set the desired value, proceed as shown on the display.

The value is saved automatically.

5.6.1 Setting the maximum speed

▶ Select speed display.

▶ Slide the slider to the desired value or touch the plus or minus area.

The value is saved automatically.

▶ Press the back key to close the speed setting.

5.6.2 Setting the torque limit

Note

The MASTERsurg LUX Wireless reduces the power to prevent the maximal torque
setting from being exceeded. This may lead to the motor coming to a standstill if the
rotating handpiece is blocked.

▶ Select the torque display.

Note

The torque values can deviate by max. ± 10 % with the KaVo contra-angle hand­pieces SURGmatic S201. Larger deviations are possible with other contra-angle
handpieces.

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5 Operation | 5.6 Changing default values

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▶ Slide the slider to the desired value or touch the plus or minus area.

The value is saved automatically.

▶ Press the back key to close the speed setting.

The maximal torque value reached is displayed during the treatment in the activities
"Cut thread", "Place implant" and "Set closure cap". The value is re-set as soon as the
motor starts again.

5.6.3 Setting the coolant flow

CAUTION

Coolant dosed incorrectly.
Tissue damage.

▶ Please note the instructions for use of the attachment tool.
▶ Set the coolant flow sufficiently high.

The coolant flow rate can be set to 4 levels or switched off:

▪ Off

▪ Level 1 = approx. 32 ml/min

▪ Level 2 = approx. 50 ml/min

▪ Level 3 = approx. 76 ml/min

▪ Level 4 = approx. 110 ml/min

Instructions for use MASTERsurg LUX Wireless REF 1.009.1200

5 Operation | 5.6 Changing default values

▶ Touch the coolant display until the supply rate is set as desired.

The value is saved automatically.

The coolant flow can be set and switched on or off during the treatment using the
pump key of the wireless foot control. The pump key has two operating modes.

See also:

2 5.2.6 Setting the operating mode of the pump key of the foot control, Page 33

The changed value is shown on the display and is then available for the next use.

See also:

2 5.11 Wireless foot control, Page 52

5.6.4 Changing the direction of motor rotation

▶ Touch Direction of motor rotation in order to change the direction of motor rota-

tion.

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5 Operation | 5.7 Rinsing function

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The direction of motor rotation can be changed during the treatment using the direc­tion of motor rotation key of the wireless foot control. The changed direction of motor
rotation is shown on the display. For safety reasons, running in counterclockwise dir­ection is not saved.

See also:

2 5.11 Wireless foot control, Page 52

Three audible signals indicate counterclockwise rotation. When the motor starts up, 3
more audible signals are issued.

Note

The set torque automatically increases by 5 Ncm. The maximum torque of the se­lected activity cannot be exceeded.

5.6.5 Setting the transmission ratio

▶ Touch the transmission ratio display to set the value as desired.

The value is saved automatically.

See also:

2 Example 2: Program steps that do not include the activity, "Cut thread", and in-

clude the "Rinsing function" activity, Page 42

5.7 Rinsing function

5.7.1 Manual rinsing function

Instructions for use MASTERsurg LUX Wireless REF 1.009.1200

5 Operation | 5.7 Rinsing function

The rinsing function serves to feed liquid and to start-up the illumination on the hand­piece. The motor is not activated during this process. The rinsing function can be
called up manually at any time.

▶ Press the pump key on the wireless foot control for an extended time to activate

the rinsing function.

▶ Press the speed key on the wireless foot control to start the rinsing function and

control the coolant flow.

▶ To terminate the rinsing function, press the back key or the pump key.

5.7.2 Program activity rinsing function

The rinsing function serves to feed liquid and to start-up the illumination on the hand­piece. The motor is not activated during this process. The rinsing function can be
defined as an activity in the course of the program.

▶ Defining and executing program steps.

See also:

2 Example 2: Program steps that do not include the activity, "Cut thread", and in-

clude the "Rinsing function" activity, Page 42

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Instructions for use MASTERsurg LUX Wireless REF 1.009.1200

5 Operation | 5.8 Activating the one-touch calibration

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5.8 Activating the one-touch calibration

The one-touch calibration automatically compensates for torque deviations of the mo­tor that may be caused, e.g., by aging processes. When the handpiece is attached,
the unit detects if the handpiece runs sluggish or is defective. The one-touch calibra­tion thus provides for a more accurate torque on the contra-angle handpiece.

Note

The handpiece must be attached for calibration.
One-touch calibration should be carried out only with KaVo surgical handpieces

with a transmission ratio of 16:1, 20:1 or 27:1.
The one-touch calibration cannot be carried out with third-party handpieces or

handpieces with different transmission ratios.
The calibration must be repeated whenever the handpiece is changed.

▶ Touch the calibration symbol in order to start the One-Touch calibration.

The display shows "Press wireless foot control".

CAUTION

The motor starts at full speed.
Risk of injury.

▶ Hold the motor firmly or put it in a safe holder during the calibration.

▶ Press the wireless foot control and hold it down until the display shows that "Calib-

ration was successful".

▶ If you release the wireless foot control before the display shows that the calibra-

tion was successful, press the wireless foot control again until the display shows
that the calibration was successful.

▶ Press the back key to terminate the calibration and to return to the selection of

device settings.

If an unsuitable or defective handpiece was used in the calibration, the calibration is
discontinued and the error message, "Measurement failed undefined error", is shown.

▶ Press the back key to terminate the failed calibration.

See also:

2 8 Troubleshooting, Page 64

Instructions for use MASTERsurg LUX Wireless REF 1.009.1200

5 Operation | 5.9 Implant position

5.9 Implant position

The implant position can be entered as a two-digit number. The entry can be made
either in the FDI (ISO system) or in the Universal Numbering System (American Sys­tem).

The implant position can be entered in any step of the program and is recorded if doc­umentation is enabled.

See also:

2 5.2.2 Setting the documentation, Page 32

5.10 Documentation

The documentation function of the MASTERsurg LUX Wireless allows the date, time,
torque, speed, direction of rotation, program name, implant position, activity, transmis­sion ratio, pump level, software version and serial number of the unit to be recorded.

Three modes are available:

▪ Implant: A torque plot is shown in the "Set implant" activity after each motor stop.

The plot visualises the torque profile applied during insertion of the implant (yellow
line). The green line describes the maximum torque reached. The torque plot is
also stored in the <IMPxxxxx.BMP> file on the SD card. All other data are recor­ded as numerical values in the file, <IMPxxxxx.CSV>.

▪ Permanent: Documentation of the entire treatment process as numerical values in

the <REC000xx.CSV> file on SD card without BMP

▪ Off: Documentation disabled. No recording or output of the treatment data.

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5 Operation | 5.11 Wireless foot control

52 / 76

Note

In the modes, "Implant" and "Permanent", please make sure that an SD card is in­serted on the back of the unit.

Note

Please make sure that the proper implant position is selected.

Note

The torque plot can be closed by pressing one of the keys on the wireless foot con­trol or by touching the back key on the unit. The updated torque plot is displayed
again after each motor stop.

5.11 Wireless foot control

5.11.1 Changing the speed, coolant flow, and direction of motor rotation

▶ Press the speed key with your foot to start the motor and increase the speed.

▶ Depending on the pump key operating mode of the wireless foot control, press the

pump key to set the coolant flow or to switch it on or off.

▶ Press the pump key of the foot control for an extended time to activate the rinsing

function.

Instructions for use MASTERsurg LUX Wireless REF 1.009.1200

5 Operation | 5.12 Changing the coolant container

▶ Press the direction of motor rotation key of the wireless foot control to set the dir-

ection of motor rotation.

5.11.2 Selecting the program steps

Program steps can be selected during the treatment using the program key of the
wireless foot control.

▶ Press the program key of the wireless foot control

briefly

to select the next pro-

gram step.

▶ Press the program key of the wireless foot control

long

to select the previous pro-

gram step.

5.12 Changing the coolant container

The coolant container can be changed as follows:

▶ Close the hose clamp.

▶ Pull the hose and puncture needle out of the empty coolant container.
▶ Replace the empty coolant container by a full coolant container.

See also:

2 4.5 Connecting the coolant container and hose set, Page 24

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Instructions for use MASTERsurg LUX Wireless REF 1.009.1200

6 Decommissioning | 6.1 Disconnecting the electrical connection

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6 Decommissioning

6.1 Disconnecting the electrical connection

▶ Turn the device off.
▶ Disconnect the power cable the socket of the supply mains.
▶ Disconnect the power cable from the device.

6.2 Disposal of the coolant hose

Note

The coolant hose with accessories needs to be exchanged and discarded after
each treatment.

2

3

▶ Close the hose clamp ①.
▶ Pull the puncture needle ② out of the coolant container.
▶ Open the lock ③ and remove the hose.

Instructions for use MASTERsurg LUX Wireless REF 1.009.1200

6 Decommissioning | 6.3 Disconnecting the surgical motor

▶ Remove the hose set from the unit and discard it.

6.3 Disconnecting the surgical motor

▶ Disconnect the plug of the motor cable from the connector on the device. Make

sure to grasp the plug as close to the device as possible.

Note

Cleaning and disinfecting the motor connected with the motor lead.

See also:

2 Instructions for use INTRA LUX S600 LED

6.4 Decommissioning the wireless foot control

▶ Pull the clip out of the wireless foot control.

55 / 76

Instructions for use MASTERsurg LUX Wireless REF 1.009.1200

6 Decommissioning | 6.4 Decommissioning the wireless foot control

56 / 76

1

2

▶ On the underside of the wireless foot control, press down the snap-in lug ① of the

speed button ② and take the speed button ② off the wireless foot control.

1

▶ Pull the button bar ① including the pump button, program button, and motor direc-

tion button slightly upwards and take it off the wireless foot control.

▶ Turn the lid to the left and take it off.
▶ Take out 3 alkaline type AA/ LR6 batteries and disposed them properly, if applic-

able.

▶ Place the lid on the unit (arrow points at "Open" symbol) and close it by turning it

clockwise (arrow points at "Closed" symbol).

Instructions for use MASTERsurg LUX Wireless REF 1.009.1200

6 Decommissioning | 6.5 Dismantling the bottle holder

1

2

222

3

▶ Plug the button bar ① onto the wireless foot control ② and press it on lightly until

the button bar ① snaps into place ③.

1

2

333

333

4

▶ Plug the speed button ① onto the wireless foot control and press it on lightly until

the snap-in lug ② snaps in. Make sure that the foot pedal springs are situated in
the recesses of the housing ③.

6.5 Dismantling the bottle holder

The bottle holder can be disassembled if the device is to be stored, shipped or dis­posed in space-saving manner.

▶ Press down the click-stop knob on the bottom side of the unit and pull off the

bottle holder ① towards the back.

57 / 76

Instructions for use MASTERsurg LUX Wireless REF 1.009.1200

7 Reprocessing steps in accordance with DIN EN ISO 17664 | 7.1 Cleaning

58 / 76

7 Reprocessing steps in accordance with DIN EN ISO 17664

Note

The reprocessing steps for surgical motors with motor cable and for the straight and
contra-angle handpieces are described in the corresponding Instructions for use.

Note

The instructions for cleaning and sterilisation have been validated by the manufac­turer. Any departure from the instructions provided must be checked by the user for
efficacy and possible detrimental consequences.

7.1 Cleaning

7.1.1 Manual cleaning

▶ Use a moist disposable cloth to wipe down all visible surfaces of the unit, bottle

holder, wireless foot control surfaces, and connecting cables.

Cleaning the wireless foot control

1

2

▶ On the underside of the wireless foot control, press down the snap-in lug ① of the

speed button ② and take the speed button ② off the wireless foot control.

1

Instructions for use MASTERsurg LUX Wireless REF 1.009.1200

7 Reprocessing steps in accordance with DIN EN ISO 17664 | 7.1 Cleaning

▶ Pull the button bar ① including the pump button, program button, and motor direc-

tion button slightly upwards and take it off the wireless foot control.

▶ Clean the individual parts of the wireless foot control under running water and

then dry them.

1

2

222

3

▶ Plug the button bar ① onto the wireless foot control ② and press it on lightly until

the button bar ① snaps into place ③.

1

2

333

333

4

▶ Plug the speed button ① onto the wireless foot control and press it on lightly until

the snap-in lug ② snaps in. Make sure that the foot pedal springs are situated in
the recesses of the housing ③.

Note

The lid ④ needs to stay closed while the wireless foot control is being cleaned.

59 / 76

Instructions for use MASTERsurg LUX Wireless REF 1.009.1200

7 Reprocessing steps in accordance with DIN EN ISO 17664 | 7.2 Disinfection

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7.1.2 Machine cleaning

CAUTION

Damage by liquids.
Faults on electrical components.

▶ Do not machine-clean the device.

The following parts of the unit are released for machine-based cleaning:

▪ Handpiece tray

▪ Motor and motor cable

Note

Please comply with the corresponding Instructions for use when you re-process the
motor and motor cable.

The re-processing steps for the handpiece tray are as follows:

KaVo recommends washer disinfectors in compliance with EN ISO 15883-1 that are
operated with alkaline cleaning agents.
The validations were conducted with the VARIO-TD program, the cleaning agent
neodisher® MediClean and the neutralisation agent neodisher® Z.

▶ For program settings as well as cleansers and disinfectants to be used, please

refer to the Instructions for Use of the thermodisinfector.

7.2 Disinfection

Note

After each treatment of a patient, the surfaces near the patient that may have been
contaminated by contact or aerosol need to be disinfected. All disinfection meas­ures need to be carried out by wipe disinfection.

Note

Please comply with the corresponding Instructions for use when you re-process the
motor and motor cable.

7.2.1 Manual disinfection

▶ Use a soft disposable cloth and an approved disinfectant for disinfection by wiping

down all visible surfaces of the unit, bottle holder, wireless foot control surfaces,
and connecting cables. Make sure that all surfaces are wetted.

▶ Let the disinfectant act for the prescribed time.
▶ Dry the surfaces.

Permissible disinfectants (application range in accordance with the available manufac­turer's instructions and national guidelines. Please note material safety data sheets.)
KaVo recommends the following products based on the compatibility of the materials.
The microbiological efficacy must be confirmed by the disinfectant manufacturer.

▪ FD 322 Dürr

▪ Microcide AF Liquid (Schülke & Mayr)

▪ CaviCide made by Metrex

Instructions for use MASTERsurg LUX Wireless REF 1.009.1200

7 Reprocessing steps in accordance with DIN EN ISO 17664 | 7.3 Packaging

7.2.2 Automated disinfection

The following parts of the unit are released for machine-based disinfection:

▪ Handpiece tray

▪ Motor and motor cable

Note

Please comply with the corresponding Instructions for use when you re-process the
motor and motor cable.

The re-processing steps for the handpiece tray are as follows:

KaVo recommends washer disinfectors in compliance with EN ISO 15883-1 that are
operated with alkaline cleaning agents.
The validations were conducted with the VARIO-TD program, the cleaning agent
neodisher® MediClean and the neutralisation agent neodisher® Z.

▶ For program settings as well as cleansers and disinfectants to be used, please

refer to the Instructions for Use of the thermodisinfector.

7.2.3 Drying

Note

Coolant hose with accessories is intended for single use only and is not to be disin­fected and sterilised. No drying required.

▶ Allow all disinfected and and sterilised parts to dry fully on room air before using

them again.

Automatic Drying

The drying procedure is usually part of the cleaning programme of the washer disin­fector.

▶ Follow the instructions for use of the thermodisinfector.

7.2.4 Service, inspection and testing after preparation

Note

It is essential to comply with the hygiene requirements (sterility) during the test after
reprocessing. If sites of fracture and clear changes of the surface are visible, the
parts need to be checked by the Service.

Check for cleanliness, intactness, servicing, and repair as described in the following:

▶ Check the adjustable functions of the unit and the motor function.
▶ Check the hose pump for sufficient coolant flow rate.
▶ Check the control commands on the wireless foot control.

7.3 Packaging

Note

The quality and use of the sterilisation packaging must comply with applicable
standards and be suitable for the sterilisation procedure!

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Instructions for use MASTERsurg LUX Wireless REF 1.009.1200

7 Reprocessing steps in accordance with DIN EN ISO 17664 | 7.4 Sterilisation

62 / 76

Note

If potentially infectious liquids and particles can contact the products, it is recom­mendable to cover and protect these areas with sterile disposable products.

▶ Seal the handpiece tray and motor cable in a sterilisation pouch.

7.4 Sterilisation

Note

Please comply with the corresponding Instructions for use when you re-process the
motor and motor cable.

Sterilisation by moist heat in accordance with ISO 17665-1 in a steam
steriliser (autoclave)

CAUTION

Damage to device due to improper sterilisation.
Damage to the sterile device.

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

oxide!

CAUTION

Product damage
Contact corrosion

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

drying.

Note

Treating patients who are possibly afflicted by an acute, critical infectious disease,
be sure to comply with the hygienic measures cited in applicable publications and
reports. If possible, use suitable disposable devices to avoid the transmission of
critical pathogens. This concerns the protection of the user, patients and all parti­cipants in the surgery.

All dental and medical materials considered to be contaminated must be suitably
processed and sufficiently identified after cleaning and sterilisation before returning
them.

Note

The user is responsible for observing the regulations and conditions for sterility. The
coolant container needs to be disposed and the hoses need to be changed after
each patient.

KaVo medical devices released for sterilisation are temperature-resistant up to 138 ℃
(280.4 °F).

The following parts are released for sterilisation:

▪ Motor cable

▪ Handpiece tray

▪ Autoclave with 3-fold fractionated pre-vacuum:

- at least 3 minutes at 134 °C -1 °C / +4 °C (273 °F -1.6 °F / +7.4 °F)

– Drying time: 20 min.

▪ Autoclave using the gravitation method

Instructions for use MASTERsurg LUX Wireless REF 1.009.1200

7 Reprocessing steps in accordance with DIN EN ISO 17664 | 7.4 Sterilisation

- at least 10 minutes at 134 °C -1 °C / +4 °C (273 °F -1.6 °F / +7.4 °F)

– Drying time: 30 min.

Note

Allow the sterilised items to cool to room temperature before using them again.

7.4.1 Storage

Observe all necessary measures for hygiene when storing sterile goods. Store protec­ted from dust and in a dry place, release with identification on the packaging. Evaluate
the duration of storage.

63 / 76

Instructions for use MASTERsurg LUX Wireless REF 1.009.1200

8 Troubleshooting

64 / 76

8 Troubleshooting

Note

If malfunctions cannot be located or eliminated using this troubleshooting guide, a
technician trained by KaVo must be commissioned to eliminate the problem.

Note

The permitted work is described in the Technician's Instructions available to the
trained service staff.

In case of malfunction, the display names the malfunction directly or shows an error
number.

Malfunction Cause Remedy

Non-functional device. The unit is switched off.

▶ Switch-on the mains switch on the rear of the unit.

Neither end of the power

cable is plugged in.

▶ Plug in the power input cable.

Unknown.

▶ Turn the unit off and on.

Blown fuse.

▶ Contact customer service.

No coolant in the hand-

piece.

No coolant flow pre-selec-

ted.

Pump is off.

▶ Pre-select coolant flow.

See also:

2 5.6.3 Setting the coolant flow, Page 46

Hose fixation is not

plugged in.

▶ Plug in the hose fixation.

See also:

2 4.5 Connecting the coolant container and hose set,

Page 24

Bottle is empty.

▶ Connect new bottle.

Hose clamp is closed.

▶ Open the hose clamp.

Pump locking mechanism

is not closed.

▶ Check and close, if needed, the closing mechan-

ism.

Hose is kinked.

▶ Check hose and remove the kink, if any.

Glass bottle containing the

coolant is not ventilated.

▶ Open the cap on the ventilation valve of the punc-

ture needle.

Insufficient coolant flow in

the instrument.

Spray nozzles are crusty

or soiled.

▶ Clean the spray nozzles with the nozzle needle or

re-process the part.

See also:

2 SURGmatic Instructions for use

Glass bottle containing the

coolant is not ventilated.

▶ Open the cap on the ventilation valve of the punc-

ture needle.

The motor makes a grind-

ing noise or does not run

smoothly.

The motor is not correctly

plugged on or screwed on.

▶ Firmly insert the motor hose into the housing.
▶ Firmly screw on the motor hose to the motor.
▶ Check if all the connections and couplings are

firmly seated.

Instructions for use MASTERsurg LUX Wireless REF 1.009.1200

8 Troubleshooting

Malfunction Cause Remedy

No light on the straight or

contra-angle handpiece

The light is not turned on.

▶ Turn on the light.

See also:

2 5.2.3 Setting the LUX brightness, Page 32

The straight and contra-

angle handpiece is improp-

erly attached.

▶ Attach the straight and contra-angle handpiece un-

til the catch audibly locks.

Defective LED.

▶ Replace the LED.

See also:

2 Instructions for use INTRA LUX S600 LED

Not a suitable straight and

contra-angle handpiece.

▶ Use a suitable light, straight and contra-angle

handpiece.

Error message from software

Malfunction Cause Remedy

Event E3:

Release the foot pedal

Wireless foot control was

actuated while the unit

started up.

▶ Release the wireless foot control.

Event E4:

Data initialisation

Setting data newly initial-

ised.

▶ Confirm message and check or correct the pro-

gram settings.
If the problem persists, notify service engineer

Event E6:

Internal communication er-

ror

Internal system error.

▶ Turn the unit off and on. If the problem persists,

notify service engineer.

Event E9:

Setting the time and date

Time was not reset after

re-start.

▶ Setting the date and time.
▶ If the problem persists, have a service engineer re-

place the battery of the real-time clock.

Event E14:

Is shown at start-up if the

battery level is low

Battery level low.

▶ Batteries (alkaline type AA/ LR6) must be supplied

and replaced soon. Confirm the message to be
able to continue working.

Event E14:

Is shown approximately

every 10 min if battery

level is low

Battery level critical.

▶ Batteries (alkaline type AA/ LR6) must be replaced

instantaneously to be able to continue working.

Event E29:

SD card write protection

SD memory card is write-

protected or defective.

▶ Switch the write-protect switch on the left side of

the card upwards to "unlock", "write" or the like.

▶ If the problem persists, use a new SD memory

card.

▶ If the problem persists, notify service engineer.

All events > 30:

Hardware error

Internal system error.

▶ Turn the unit off and on. If the problem persists,

notify service engineer.

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Instructions for use MASTERsurg LUX Wireless REF 1.009.1200

8 Troubleshooting

66 / 76

Malfunction Cause Remedy

Events E36 and E37:

Motor overload

Overtemperature on stator.

Over-current > nominal

current.

▶ Let the motor rest. If the problem persists, notify

service engineer.

Event E47 Residual moisture in the

plug of the motor cable can

lead to false recognition of

an E47 error during the

start-up test of the device.

▶ Turn the device off.
▶ Disconnect the motor cable from the device.
▶ Turn the device on.
▶ Connect the motor cable.
▶ Make sure that water cable and motor plug are ab-

solutely dry.

▶ Do not drive with compressed air as this may drive

liquid into the plug.

▶ If the problem persists, notify service engineer.

Wireless foot control sym-

bol has a yellow back-

ground

Wireless foot control mal-

function.

▶ Reconnect the wireless foot control.

See also:

2 5.2.7 Connect the wireless foot control, Page 34

▶ Check if the wireless foot control is installed cor-

rectly.

▶ If the problem persists, notify service engineer.

One-touch calibration

failed.

Straight or contra-angle

handpiece is too sluggish.

▶ Perform a run in the absence of the straight or con-

tra-angle handpiece.

ð If no error message is displayed, the handpiece

runs too sluggish.

▶ Use a different straight or contra-angle handpiece.

If the run in the absence of

the straight or contra-angle

handpiece again produces

an error message, the mo-

tor torque is too low.

▶ Use a different motor; possibly return the motor for

repair.

Motor symbol has a yellow

background.

No motor attached.

▶ Connect the motor.

Pump symbol has a yellow

background.

Hose fixation is not

plugged in.

▶ Plug in the coolant hose.

Service symbol is green Service is due soon.

▶ Arrange a precautionary appointment at a KaVo

subsidiary or with a KaVo authorised dealer.

Service symbol is yellow Service period is expired.

▶ Arrange an appointment at a KaVo subsidiary or

with a KaVo authorised dealer.

Service symbol is red Service overdue: > 4

months

▶ Arrange an appointment immediately at a KaVo

subsidiary or with a KaVo authorised dealer.

Error message "SD card

defective" during software

update

SD card is formatted incor-

rectly or SD card is defect-

ive.

▶ Format SD card in FAT16 or FAT32 format or use

new CD card. Then repeat the updating process.

Hardware error Internal system error.

▶ Turn the unit off and on. If the problem persists,

have the service staff repair the unit.

Instructions for use MASTERsurg LUX Wireless REF 1.009.1200

9 Run a software update

9 Run a software update

Please proceed as follows to update the software:

▶ Download the current firmware file from www.kavo.de/produkte.
▶ Copy the firmware file to an SD card (storage capacity 1 - 32 GB, FAT format).
▶ Turn the device off.
▶ Insert the SD card with the new firmware file into the unit. Make sure that only a

single firmware file with the .bin file extension (the downloaded current file) is
stored on the SD card.

▶ Turn the device on.

ð The update process starts automatically.

Note

The unit must not be turned off during the update process.

After the update process, the unit starts using the updated software.

WARNING

Malfunctions of the unit.
The software version displayed on the start screen or in the version display must co-

incide with the software version that was downloaded. If these do not coincide or if
there is any other error, please contact Customer Service.

See also:

2 5.2.17 Version, Page 37

Note

All program and device settings remain unchanged.

67 / 76

Instructions for use MASTERsurg LUX Wireless REF 1.009.1200

10 Safety checks ("STK")

68 / 76

10 Safety checks ("STK")

The MASTERsurg LUX Wireless must be subjected to a service check including
safety check ("STK") every 2 years. The safety check may only be done by a profes­sional trained by KaVo or in a shop trained by KaVo. Perform the safety check ("STK")
as described in the KaVo technician's instructions.

The urgency of the service check is indicated on the display by a symbol in "traffic light
colours".

Symbol Description

green

Service check is soon due.

▶ Arrange a precautionary appointment at a KaVo subsidiary or with a

KaVo-authorised dealer.

yellow

Service check is due.

▶ Arrange an appointment at a KaVo subsidiary or with a KaVo-authorised

dealer.

red

Service check is over-due.

▶ Arrange an appointment immediately at a KaVo subsidiary or with a

KaVo-authorised dealer.

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]
[e-mail]
KaVo Dental GmbH
Repairs
Bahnhofstr. 18
88447 Warthausen

Instructions for use MASTERsurg LUX Wireless REF 1.009.1200

11 Accessories

11 Accessories

The following accessories are approved for the MASTERsurg LUX Wireless:

▪ Hose set sterile S600 (10 pcs.) (

Mat. no. 1.009.8757

)

▪ Hose set sterilisable S600 (

Mat. no. 1.011.0633

)

▪ Handpiece tray (

Mat. no. 1.009.3411

)

▪ Motor INTRA LUX S600 LED (

Mat. no. 1.008.8000

)

▪ Motor cable S600 (

Mat. no. 1.009.1700

)

▪ Wireless foot control (

Mat. no. 1.010.0289

)

▪ Cable-type foot control (

Mat. no. 1.010.0288

)

▪ KaVo SURGmatic straight and contra-angle handpieces

69 / 76

Instructions for use MASTERsurg LUX Wireless REF 1.009.1200

12 Information about electromagnetic compatibility | 12.1 Guidelines and manufacturer's declaration - electromagnetic emis­sion

70 / 76

12 Information about electromagnetic compatibility

12.1 Guidelines and manufacturer's declaration - electromagnetic

emission

The MASTERsurg LUX Wireless is intended for use in an environment as specified
below. The MASTERsurg LUX Wireless customer or user must ensure that the unit is
used in an environment matching the description.

Measurements of emitted interfer­ence

Conformance Electromagnetic environment -

Guidelines

HF emissions according to CISPR11Group 1 The MASTERsurg LUX Wireless

uses HF energy exclusively for its
internal operation. Therefore, the
HF emission of the device is very
low and interference with adjacent
electronic devices is unlikely.

HF emissions according to CISPR11Class B The MASTERsurg LUX Wireless is

intended for use in all facilities in­cluding residential ones, and facilit­ies that are directly connected to a
public power supply that also sup­plies residential buildings.

Emission of harmonics according to
IEC 61000-3-2

Class A The MASTERsurg LUX Wireless is

intended for use in all facilities in­cluding residential ones, and facilit­ies that are directly connected to a
public power supply that also sup­plies residential buildings.

Emission of voltage fluctuations/
flicker according to IEC 61000-3-3

complies The MASTERsurg LUX Wireless is

intended for use in all facilities in­cluding residential ones, and facilit­ies that are directly connected to a
public power supply that also sup­plies residential buildings.

Note

The device or system may not be used or stacked directly next to other devices. If it
has to be used close to or stacked next to other devices, the device or system must
be monitored to ensure that it is used properly in the existing arrangement.

Note

The immunity test levels required in IEC 60601-1-2 (DIN EN 60601-1-2) are met.

12.2 Guidelines and manufacturer's statement - Electromagnetic

immunity

The MASTERsurg LUX Wireless is intended for use in an environment as specified
below. The MASTERsurg LUX Wireless customer or user should ensure that the unit
is used in an environment matching the description.

Instructions for use MASTERsurg LUX Wireless REF 1.009.1200

12 Information about electromagnetic compatibility | 12.3 Guidelines and manufacturer's statement - Electromagnetic im-

munity

Interference immunity tests IEC 60601 test levels Compliance level Electromagnetic environ-

ment - Guidelines

Electrostatic discharge
(ESD) according to IEC
61000-4-2

± 6 kV contact discharge
± 8 kV atmospheric dis­charge

± 6 kV contact discharge
± 8 kV atmospheric dis­charge

Floors should be made of
wood or concrete or be fit­ted with ceramic tiles. If the
floor is fitted with synthetic
material, the relative hu­midity must be at least 30
%.

Fast transient electrical in­terference / bursts accord­ing to IEC 61000-4-4

± 2 kV for power lines ± 2 kV for power lines The quality of the supply

voltage should correspond
to that of a typical business
or hospital environment.

Surges according to IEC
61000-4-5

± 1 kV push-pull voltage
(symmetrical)
± 2 kV common mode
voltage
(unsymmetrical)

± 1 kV push-pull voltage
(symmetrical)
± 2 kV common mode
voltage
(unsymmetrical)

The quality of the supply
voltage should correspond
to that of a typical business
or hospital environment.

Voltage interruptions,
short-term interruptions,
and fluctuations of the sup­ply voltage according to
IEC 61000-4-11

< 5 % U

T

for 1/2 period
(> 95 % interruption)
40 % U

T

for 5 periods
(60 % interruption)
70 % U

T

for 25 periods
(30 % interruption)
< 5 % U

T

for 5 s
(> 95 % interruption)

< 5 % U

T

for ½ period
(> 95 % interruption)
40 % U

T

for 5 periods
(60 % interruption)
70 % U

T

for 25 periods
(30 % interruption)
< 5 % U

T

for 5 s
(> 95 % interruption)

The quality of the supply
voltage should correspond
to that of a typical business
or hospital environment. If
the user of the MASTER­surg LUX Wireless needs
uninterrupted function of
the unit even when the
power supply is interrup­ted, it is recommended to
supply the MASTERsurg
LUX Wireless from an un­interruptible power system
or a battery.

Magnetic field at a supply
frequency (50/60 Hz) ac­cording to IEC 61000-4-8

3 A/m 3 A/m Magnetic fields at the

mains frequency should
correspond to typical val­ues in a business and
hospital environment.

Note: U T is the alternating mains voltage before the application of the test level.

12.3 Guidelines and manufacturer's statement - Electromagnetic

immunity

The MASTERsurg LUX Wireless is intended for use in an environment as specified
below. The MASTERsurg LUX Wireless customer or user should ensure that the unit
is used in an environment matching the description.

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Instructions for use MASTERsurg LUX Wireless REF 1.009.1200

12 Information about electromagnetic compatibility | 12.4 Recommended safe distances between portable and mobile HF
telecommunications equipment and the MASTERsurg LUX Wireless

72 / 76

Interference immunity
tests

IEC 60601 test levels Compliance level Electromagnetic environment -

Guidelines

Wire-based HF interfer­ence according to IEC
61000-4-6
Wireless HF interfer­ence according to IEC
61000-4-3

3 V

eff

150 kHz to 80 MHz
3 V/m
800 MHz to 2.5 GHz

3 V

eff

3 V/m

Portable and mobile radio devices
should not be used closer to the
MASTERsurg LUX Wireless includ­ing the cables than the recommen­ded safe distance calculated using
the equation for the transmission
frequency.
Recommended safe distance:
d = [3.5/3]P = 1.17

P

d= [3.5/3]P =1.17P for 80 MHz to
800 MHz
d= [7.0/3]P = 2.33P for 800 MHz
to 2.5 GHz
where P is the maximal nominal
power of the transmitter in watts
(W) as specified by the transmitter
manufacturer and d is the recom­mended safe clearance in metres
(m).
The field strength of stationary wire­less radio transmitters as measured
locallya should be lower than the
conformance level at all frequen­cies.

b

Interference is possible in the vicin­ity of devices that bear the following
symbol.

Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not be applicable in every case. The propagation of
electromagnetic waves is subject to absorption and reflection by buildings, objects,
and people.

a

The field strength of stationary transmitters such as base stations of mobile tele­phones and land mobile radio devices, amateur radio stations, AM and FM radio and
television broadcasting stations cannot be determined based on theoretical considera­tions. A site study should be considered to determine the electromagnetic environment
in terms of stationary transmitters. If the field strength measured at the location at
which the MASTERsurg LUX Wireless is used exceeds the conformity levels specified
above, the MASTERsurg LUX Wireless should be monitored to confirm that it is func­tioning as intended. Should unusual performance features be observed, additional
measures may be required, such as, e.g., a different alignment or another location for
the MASTERsurg LUX Wireless.

b

In the frequency range of 150 kHz to 80 MHz, the field strength should be less than
3V

eff

V/m.

12.4 Recommended safe distances between portable and mobile HF
telecommunications equipment and the MASTERsurg LUX Wireless

The MASTERsurg LUX Wireless is intended for use in an electromagnetic environ­ment like the one specified below. The customer or user of the MASTERsurg LUX
Wireless can help to avoid electromagnetic interference by complying with the min-

Instructions for use MASTERsurg LUX Wireless REF 1.009.1200

12 Information about electromagnetic compatibility | 12.4 Recommended safe distances between portable and mobile HF

telecommunications equipment and the MASTERsurg LUX Wireless

imum safe distance between portable and mobile HF-telecommunication devices
(transmitters) and the MASTERsurg LUX Wireless - dependent on the output power of
the communication device - as given below.

Rated power of the trans­mitter in W

150 kHz to 80 MHz
d=1.17

P

80 MHz to 800 MHz
d=1.17

P

800 MHz to 2.5 GHz
d=2.33

P

0.01 0.12 0.12 0.23

0.1 0.37 0.37 0.74

1 1.17 1.17 2.33

10 3.70 3.70 7.37

100 11.70 11.70 23.30

For transmitters whose maximum rated power is not included in the above table, the
recommended safe distance d in metres (m) can be calculated using the equation for
the respective column, where P is the maximum rated power of the transmitter in
Watts (W) as specified by the manufacturer.

Note 2: These guidelines may not be applicable in every case. The spread of electro­magnetic waves is absorbed and reflected by buildings, objects and people.
Comment 1: To calculate the recommended safe distance from transmitters with a fre­quency range of 80 MHz to 2.5 GHz, an additional factor of 10/3 was used to reduce
the probability that a mobile/portable communication unit that is inadvertently brought
into the patient area would cause malfunction.

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1.010.3594 · bd · 20161206 - 04 · en