W & H Implantmed SI-1015 Instructions for Use

Contents Symbols........................................................................................................................................................................................................... 4 1. Introduction................................................................................................................................................................................................ 9 2. Electromagnetic compatibility (EMC).................................................................................................................................................... 11 3. Unpacking..................................................................................................................................................................................................12 4. Scope of delivery.......................................................................................................................................................................................13 5. Safety notes..............................................................................................................................................................................................14 6. Description of front panel........................................................................................................................................................................................ 22 of rear panel......................................................................................................................................................................................... 23 of foot control S-N2/S-NW................................................................................................................................................................... 24 of motor with cable.............................................................................................................................................................................. 26 7. Start-up...................................................................................................................................................................................................... 27 8. Control unit............................................................................................................................................................................................... 28 9. Icons Navigation............................................................................................................................................................................................ 29 Information.......................................................................................................................................................................................... 30 Main menu............................................................................................................................................................................................ 31 Programs.............................................................................................................................................................................................. 32 Setup.................................................................................................................................................................................................... 33 10. Starting operation.................................................................................................................................................................................. 35 11. Control unit operation Main menu............................................................................................................................................................................................ 36 Factory settings................................................................................................................................................................................... 38 Setup.................................................................................................................................................................................................... 44 System................................................................................................................................................................................................. 45 Documentation (DOKU)....................................................................................................................................................................... 47 2

Contents 12. Error messages....................................................................................................................................................................................... 49 13. Hygiene and maintenance General notes....................................................................................................................................................................................... 51 Limitations on processing................................................................................................................................................................... 52 Initial treatment at the point of use................................................................................................................................................... 53 Manual cleaning................................................................................................................................................................................... 54 Manual disinfection............................................................................................................................................................................. 55 Automated cleaning and disinfection................................................................................................................................................ 56 Drying................................................................................................................................................................................................... 57 Inspection, Maintenance and Testing................................................................................................................................................. 58 Packaging............................................................................................................................................................................................. 59 Sterilization.......................................................................................................................................................................................... 60 Storage..................................................................................................................................................................................................61 14. Servicing................................................................................................................................................................................................. 62 15. W&H accessories and spare parts........................................................................................................................................................ 64 16. Technical data......................................................................................................................................................................................... 66 17. Disposal................................................................................................................................................................................................... 68 W&H course certificate................................................................................................................................................................................ 69 Explanation of warranty terms.................................................................................................................................................................... 73 Authorized W&H service partners................................................................................................................................................................74 3

Symbols WARNING! (if persons could be injured)

in the Instructions for Use

ATTENTION! (if property could be damaged)

General explanations, without risk to persons or property

Thermo washer disinfectable

Sterilizable up to the stated temperature

Call customer service

4

Symbols Follow Instructions for Use

Class II equipment

Consult Instructions for Use

Foot control

Date of manufacture

On / Off

Do not dispose of with domestic waste

Electric fuse

Data Matrix code for product information including UDI (Unique Device Identification) CE marking XXXX with identification number of the Notified Body

Type B applied part (not suitable for intracardiac application)

The medical device with reference to electrical safety, mechanical safety and fire prevention conforms to UL 60601-1:2006, CAN/CSA-C22.2 No.601.1-M90:2005, CAN/CSA-C22.2 No. 60601-1:2008, ANSI/AAMI ES 60601-1:2005 25UX (Control No.)

on the control unit Catalogue number Serial number Supply voltage of the control unit Alternating current Power consumption of the control unit Supply current Frequency of the alternating current Revolutions per minute (= rpm) 5

Symbols CE marking XXXX with identification number of the Notified Body Do not dispose of with domestic waste

Non-ionizing electromagnetic radiation Battery compartment closed

Data Matrix code for product information including UDI (Unique Device Identification) UL Component Recognition Mark indicates compliance with Canadian and U.S. requirements

Battery compartment open Category AP equipment AP

on the foot control Catalogue number Serial number Date of manufacture

6

Symbols CE marking XXXX with identification number of the Notified Body This way up Fragile, handle with care Keep dry »Der Grüne Punkt« (The Green Dot) trademark of Duales System Deutschland GmbH Trademark of RESY OfW GmbH for identification of recyclable transport and outer packaging of paper and cardboard

on the packaging Data Matrix code for product information including UDI (Unique Device Identification) Data structure in accordance with Health Industry Bar Code

+70°C(+158°F)Max. Permitted temperature range

-40 °C (-40°F) Min.

80 % 8 %

Humidity, limitation

Caution! According to Federal law, this medical device may only be sold by or on the order of a dentist, physician or any other medical practitioner licensed by the law of the State in which he or she practices and intends to use or order the use of this medical device.

7

Symbols Consult Instructions for Use CE mark XXXX with identification number of the Notified Body Batch code

Not for re-use Use by

on the irrigation tubing set Latex-free Sterilization with ethylene oxide

Caution! According to Federal law, this medical device may only be sold by or on the order of a dentist, physician or any other medical practitioner licensed by the law of the State in which he or she practices and intends to use or order the use of this medical device.

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1. Introduction For your safety and the safety of your patients These Instructions for Use explain how to use your product. However, we must also warn against possible hazardous situations. Your safety, the safety of your team and, of course, the safety of your patients, are of paramount importance to us. Observe the safety notes. Intended use Mechanical drive unit with coolant supply for transmission instruments with ISO 3964 (DIN 13940) compatible coupling system, for use in dental surgery, implantology and maxillofacial surgery (CMF). Misuse may damage the medical device and hence cause risks and hazards for patients, users and third parties. Qualifications of the user Only suitably qualified medical, technical and specialist trained staff may use the W&H Implantmed. We have based our developmed and design of the Implantmed on the »physician« target group. 9

Introduction Production according to EU Directive The medical device complies with the regulations of Directive 93/42/EEC. Responsibility of the manufacturer The manufacturer can only accept responsibility for the safety, reliability and performance of the Implantmed when compliance with the following instructions is ensured: >> The Implantmed must be used in accordance with these Instructions for Use. >> The Implantmed has no components that can be repaired by the user. >> Modifications or repairs must only be undertaken by an authorized W&H service partner (see page 74). >> The electrical installation at the premises must comply with the regulations laid out in IEC 60364-7-710 (“Installation of electrical equipment in rooms used for medical purposes”) or with the regulations applicable in your country. >> Unauthorized opening of the control unit invalidates all claims under warranty and any other claims. In addition to unauthorized assembly, installation, modification of or repairs to the control unit, motor with cable, transmission instrument and non-compliance with our instructions, improper use will void the warranty and release us from all other claims. 10

2. Electromagnetic compatibility (EMC) Medical electrical device is subject to particular precautions with regards to EMC and must be installed and put into operation in accordance with the EMC notes included. W&H only guarantees compliance of the control unit with the EMC Directives when it is used with original W&H accessories and spare parts. The use of accessories and spare parts that have not been approved by W&H may lead to increased emission of electromagnetic interference or to reduced resistance to electromagnetic interference. You can find the current EMC manufacturer’s declaration on our website at http://wh.com or, alternatively, you can also request a copy directly from the manufacturer. HF communication equipment Do not use any portable and mobile HF communication equipment (e.g., mobile telephones) during operation. These may affect medical electrical device. 11

3. Unpacking

 Remove the packaging.

 Remove the foot control, Instructions for Use and accessories.

 Remove the motor with cable.

 Lift out the insert with the control unit. Remove the mains cable, irrigant support, universal support, irrigation tubing set and Instructions for Use.

W&H packaging is environmentally friendly and can be disposed of by industrial recycling companies. However, we recommend that you keep the original packaging. 12

4. Scope of delivery

REF 30288000 30289000 30290000 30281000 30185000 04363600 07721800 04005900 30264000 30285000 01343700 02821400 03212700 04280600 05901800 02909300 05333500

Description Control unit SI-1023 (230 V) Control unit SI-1015 (115 V) Control unit SI-1010 (100 V) EM-19 LC motor with electrical contacts and 1.8 m cable incl. 5 hose clips EM-19 motor without electrical contacts with 1.8 m cable incl. 5 hose clips Irrigation tubing set 2.2 m (3 pcs, disposable) Universal support Irrigant support Foot control S-NW Foot control S-N2 Mains cable EU Mains cable USA, CAN, J Mains cable UK, IRL Mains cable CH Mains cable DK Mains cable AUS, NZ Mains cable BR 13

5. Safety notes

Control unit / Motor

> Before using the Implantmed for the first time, store it at room temperature for 24 hours > Check the control unit and the motor with cable for damage and loose parts every time before use. > Do not operate the control unit and the motor with cable if it is damaged. > Check the parameter settings every time the device is restarted. > Perform a test run prior to every treatment. > The responsibility for the use and timely shutdown of the system lies with the user. > Ensure that it is possible to complete the operation safely should the units or instruments fail.

The Implantmed is not approved for operation in potentially explosive atmospheres. Do not twist or kink the motor cable! Do not coil it too tightly! Moisture in the motor with cable may cause a malfunction! (Risk of short circuit)

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Safety notes

Control unit

> Use only original W&H fuses. > Never touch the patient and the electrical connections on the control unit simultaneously. > Make sure that no computer viruses are transferred to the control unit by an external data medium (USB stick).

The control unit is classed as »conventional equipment« (closed equipment without protection against the ingress of water).

Use the control unit in the WS-75 und WI-75 (20:1) ratios exclusively with the contra-angle handpieces approved by W&H. Use of other contra-angle handpieces may result in deviation from the indicated torque. The user alone is therefore responsible for the above. The manufacturer does not accept any liability.

Power failure In the event of a power failure, if the control unit is switched off, or when switching between programs, the last values set are saved and re-activated on power-up. System failure A total system failure does not constitute a critical fault. 15

Safety notes

Control unit / Motor

Mains cable / Power switch >> Only use the mains cable supplied. >> Plug the mains cable only into an earthed power socket. >> Set up the control unit so the power switch and the socket are easily accessible at all times. Disconnect the control unit from the power supply in case of danger. >> Turn off the control unit at the power switch. >> Pull the power plug out of the socket.

Rotational energy Deceleration of the bur can, cause the selected torque to be temporarily exceeded, compared to the value set, as a result of the rotational energy stored in the drive system. Observe the manufacturer’s speed and torque specifications for retaining screws for superstructures. Adjusting these retaining screws with an electric motor presents a potential risk as described above.

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Safety notes

Control unit / Motor / Foot control

Risks due to electromagnetic fields The functionality of implantable systems, such as cardiac pacemakers and implantable cardioverter defibrillator (ICD), can be affected by electric, magnetic and electromagnetic fields. >> Find out if patient and user have implanted systems before using the medical device and consider the application. >> Weigh the risks and benefits. >> Keep the medical device away from implanted systems. >> Do not place the motor on the patient’s body. >> Make appropriate emergency provisions and take immediate action on any signs of ill-health. >> Symptoms such as raised heartbeat, irregular pulse and dizziness can be signs of a problem with a cardiac pacemaker or ICD.

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Safety notes

Foot control S-NW / S-N2

Follow the directions and safety notes in the Instructions for Use of the foot control.

The foot control is approved for operation in potentially explosive atmospheres (AP).

>> Note that when using or setting low speeds, the operation or run-down of rotary instruments is more difficult to detect. >> The ESD spring contact on the bottom of the foot control must be in contact with the ground during operation. ESD is the abbreviation for “electrostatic discharge”.

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Safety notes Keep the ORANGE button depressed to switch between the control units

Foot control S-NW

Disposable batteries > Replace the disposable batteries at the first prompt (battery icon on display or LED on dongle). > Replace batteries outside explosive atmospheres only. > Pay attention to the battery icon on the display before and after each treatment.

> Dispose of faulty or flat batteries immediately and correctly via recycling systems. Do not dispose of batteries in domestic waste. > Use only high-quality disposable alkaline AA / Mignon / LR6 / 1.5 V batteries. Risk of explosion if the wrong type of battery is used. > Do not mix new, old or different types of disposable batteries. > Do not use rechargeable batteries. > When inserting disposable batteries make sure that they are correctly oriented. > Check the O-ring of the battery cover for damage. Replace a faulty or leaking O-ring immediately. > Always keep spare batteries on hand.

Disposable batteries may cause damage due to leakage or corrosion. >> Remove the disposable batteries if you are not going to use the foot control for a longer period. >> See the safety notes of the battery manufacturer. 19

Safety notes The Implantmed is designed for use with physiological saline solution.

Coolant supply

>> Always ensure correct operating conditions and that sufficient and adequate coolant is delivered. >> Always provide sufficient coolant and ensure the appropriate suction. >> Use only suitable coolants and follow the manufacturer’s medical data and instructions. >> Use the W&H irrigation tubing set or accessories approved by W&H.

Irrigation tubing set Sterile disposable irrigation tubing sets are supplied with the equipment. >> Note the expiration date and only use disposable irrigation tubing with undamaged packaging. >> Replace the disposable irrigation tubing immediately after every treatment. >> Follow your local and country-specific laws, directives, standards and guidelines for disposal.

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Safety notes Transmission instrument >> Follow the directions and safety notes in the Instructions for Use of the transmission instrument. >> Only use transmission instruments with an ISO 3964 (DIN 13940) compatible coupling system and manufacturer approved transmission instruments. >> Follow the directions of the manufacturer of transmission instrument with reference to transmission ratio, maximum speed and maximum torque. Hygiene and maintenance prior to initial use > Clean and disinfect the control unit, the motor with cable, the universal support and the irrigant support. > Sterilize the motor with cable and the universal support. 21

6. Description Display (touchscreen)

of front panel

Pump cover

Irrigant support locator

Pump cover OPEN Connection for motor 22

Description Irrigant support locator

of rear panel

Connection for foot control USB Osstell

Connection for mains cable

Power switch ON/OFF Fuse holder with 2 fuses REF 06352200 (2 x 250 V – T1.6 AH)

23

Description

Locator attach/detach

GREEN Pump ON/OFF GREY Start motor (pedal) VARIABLE or ON/OFF (Factory setting = variable) 24

of foot control S-N2/S-NW ORANGE Change program YELLOW Change motor direction Forward operation/reverse operation

Description

of foot control S-N2/S-NW

ORANGE S-N2 / S-NW: Change program Press the ORANGE button to change programs in ascending order. The motor direction is automatically set to forward operation every time the program is changed. When changing from the last program to the first program a longer acoustic signal sounds (risk of injury).

ORANGE S-NW: Switching between multiple control units Press the ORANGE button for 3 seconds

GREEN – pump ON/OFF Only when the motor is stationary can the pump be switched on or off by pressing the GREEN button of the foot control.

YELLOW – change motor direction Forward operation/reverse operation Press the YELLOW button to change from forward operation to reverse operation. A signal sounds on selection and the “Forward/reverse operation mode” symbol flashes. Before the motor starts in reverse operation, 3 audible signals are given.

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Description The motor with cable must not be disassembled. The motor with cable must not be oiled (pre-oiled for entire service life).

of motor with cable

The motor with cable is a type B applied part (not suitable for intracardiac application). Temperature information Temperature of the motor on the operator side: max. 55°C (131°F) 26

7. Start-up

Place the control unit on a flat level surface.

Ensure that the control unit can be disconnected from the power supply at any time.

 Connect the mains cable and

foot control.

S-N2

Pay attention to the

positioning!

S-NW

 Connect motor cable. Pay attention to the positioning!

 Insert the irrigant support. Pay attention to the positioning! (Maximum load capacity 1.5 kg)

 Attach the universal support and lock it.  Insert/remove the irrigation tubing. > Open the pump cover. > Insert/remove the irrigation tubing. > Close the pump cover.

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8. Control unit

Switching on the control unit  Plug the mains cable into an earthed power socket.

 Switch on the control unit at the power switch.

switching on and off Switching off the control unit  Switch off the control unit at the power switch.  Pull the power plug out of the socket.

Test run Do not hold the motor with transmission instrument at eye level. >> Connect the transmission instrument to the motor. Point the transmission instrument with the head facing downwards. >> Operate the motor with the foot control. In the event of operating malfunctions (e.g. vibrations, unusual noises or overheating), stop the motor immediately and contact an authorized W&H service partner. 28

9. Icons

Navigation

Add user

Add drill protocol

Back

Confirm/save

Edit

Help

Switch to next screen

Reduce/increase Set by pressing the minus/plus buttons or by moving the slider left or right.

29

Icons Setting selected Favorite selected black = information green = Information with selection option red = error message, work cannot be continued orange = error message, work can be continued red = replace batteries Foot control S-NW Foot control S-N2 30

Information

Icons Documentation (DOCU) New position New docu Complete docu Bar Per cent

Total Drill protocol group Drill protocol Edit Copy Rename

Activate

Main menu

Delete

Favorite

Transmission

Speed

Torque

31

Icons Program 1 (P1) Program 2 (P2) Program 3 (P3) Program 4 (P4) Thread-cutter function Program 5 (P5) Implantatinsertion Program 6 (P6) Implant stability quotient measurement W&H Osstell ISQ module is available as an accessory (REF 30210000) 32

Programs

Icons Screen lock User System Torque curve Manage user Copy Rename

Delete Activate Foot control Pairing Variable ON/OFF System check

Set screen lock Interval LED Fade-out time Sound

Setup

33

Icons Device info Service Licences Module info User interface Motor control unit Foot control 34

Osstell Software update Reset Restart Language Dental numbering system

Setup FDI (Féderation Dentaire Internationale = International dental numbering system) UNS (Universal Numbering System = American dental numbering system)

10. Starting operation The touch screen must only be touched using fingers. Using hard objects on the touch screen may scratch or damage the surface. Setting up Implantmed Switch on your control unit and follow the directions of the setup wizard. The set-up wizard guides you through the various set-up stages up to the main menu: >> Language selection >> Selection of program setting: Standard/customized

Implantology 1

16 1:1 max. 50 Ncm

40 000 rpm

Setup wizard 35

11. Control unit operation



  

Implantology 1

40 000 16



1:1



max. 50 Ncm

rpm



Main menu

 My favorites  Documentation (DOCU)  Setup  Forward/reverse operation mode  Set coolant volume 36

  Set program  Set speed / torque  Progress display mode  Programs 1 to 5

Control unit operation

Main menu

My favorites >>Select drill protocol Select drill protocol group >>Create/select/change drill protocol >>Select drill protocol: Edit, copy, rename, activate, delete, favorite An activated drill protocol cannot be deleted 16 Set program 1:1 max. 50 Ncm >>Transmission >>Speed At 40,000 rpm the accuracy of the set speed is ±10 %. >>Torque (P4, P5) Adjustment range 5 – 80 Ncm with WI-75 and WS-75 only The motor switches off automatically when the set torque is reached in forward and reverse operation modes. The accuracy of the set torque in the 20 – 50 Ncm range for the W&H WI-75 and WS-75 contra-angle handpieces is ± 10 %. Greater deviations may be encountered with other contra-angle handpieces. >>Documentation (DOCU) DOCU only appears once the documentation has been started. rpm Progress display mode (Ncm) >>Bar >>Percent >> Total 37

Control unit operation

Implantology 1

P1

Transmission Speed rpm Setting range rpm Motor direction of rotation Pump Torque Ncm 38

1:1 35,000 200 – 40,000 forward on 100 %

P2 WS-75 (20:1) 1,200 10 – 2,000 forward on 100 %

Factory settings P3 WS-75 (20:1) 800 10 – 2,000 forward on 100 %

Control unit operation

Implantology 1

P5

Transmission Speed rpm Setting range rpm Motor direction of rotation Pump Torque Ncm Setting range Ncm

WS-75 (20:1) 15 10 – 50 forward off 20 5 – 80

P5 WS-75 (20:1) 15 10 – 50 reverse off 50 5 – 80

Factory settings 39

Control unit operation

Implantology 2

P1

Transmission Speed rpm Setting range rpm Motor direction of rotation Pump Torque Ncm 40

1:1 35,000 200 – 40,000 forward on 100 %

P2 WS-75 (20:1) 1,200 10 – 2,000 forward on 100 %

Factory settings P3 WS-75 (20:1) 800 10 – 2,000 forward on 100 %

Control unit operation

Implantology 2

P4

Transmission Speed rpm Setting range rpm Motor direction of rotation Pump Torque Ncm Setting range Ncm

WS-75 (20:1) 20 10 – 50 forward on 20 5 – 80

P4 WS-75 (20:1) 20 10 – 50 reverse on 60 5 – 80

Factory settings

P5

P5

WS-75 (20:1) 15 10 – 50 forward off 20 5 – 80

WS-75 (20:1) 15 10 – 50 reverse off 50 5 – 80 41

Control unit operation

Oral Surgery

P1

Transmission Speed rpm Setting range rpm Motor direction of rotation Pump Torque Ncm 42

1:1 35,000 200 – 40,000 forward on 100 %

P2 1:1 10,000 200 – 40,000 forward on 100 %

Factory settings P3 1:2.7 108,000 540 – 108,000 forward on 100 %

Control unit operation

Factory settings

Thread-cutter function (chip breaker mode) When the pedal (grey) on the foot control is pressed, the thread cutter rotates inwards until the set torque is reached. The control unit automatically switches to reverse operation when the set torque is reached. Disengaging and then re-engaging the pedal will switch the control unit back to forward operation. If the thread cutter function is in reverse operation mode, the control unit can also start with the maximum torque.

43

Control unit operation Screen lock >>Activating / deactivating screen lock User >>Select / create user >>User settings: Copy, Rename, Activate, Delete An activated user cannot be deleted System Torque curve 44

Setup

Control unit operation Foot control S-NW: > Pairing > Properties (VARIABLE or ON/OFF) S-N2: > VARIABLE or ON/OFF System check >>Test run Set screen lock >>Activating / deactivating screen lock >>Interval: Select time LED >>Activating / deactivating LED >>Fade-out time: Select time SOUND >>Activating/deactivating sound

System 45

Control unit operation Device info >> Service >>Licences: GPL, LGPL GPL: GNU General Public License LGPL: GNU Lesser General Public License >>Module info: User interface (MMI), motor control unit, foot control, Osstell >>Software update >>Reset: Restore factory settings >>Restart: Control unit restarts automatically Language >>Select language Dental numbering system >>Select dental numbering system: FDI / UNS 46

System

Control unit operation

Documentation (DOKU)

Drill protocols, torque curves and ISQ values can only be documented in programs 4, 5 or 6. Documentation must be activated or deactivated for each program. A USB stick is required to save the documentation. >> Never remove the USB stick while the motor is running. Record documentation >> Connect USB stick Icon appears >> Enter ID >> Enter date >> Select tooth quadrant >> Select tooth >> Confirm selection Documentation starts when the motor starts. Further documentation >> Add new position >> Start new docu >> Complete docu When the motor stops, a diagram appears, which is automatically saved to the USB stick. 47

Control unit operation

Documentation (DOKU)

Edit documentation A text file (csv) and a PDF file are saved on the USB stick. The text file can be opened in Microsoft® Excel* for editing. The pdf file can be opened in Adobe® Reader®**. * Microsoft® Excel® is a registered trademark of the Microsoft® Corporation in the United States of America and/or other countries. ** Adobe® Reader® is a registered trademark of Adobe Systems Incorporated in the United States of America and/or other countries.

48

12. Error messages The error message disappears when it is clocked or when the pedal (grey) on the foot control is released.

Icon Description of error WARNING FOOT CONTROL WARNING MOTOR WARNING STORAGE DEVICE >> Insufficient memory available >> Unknown file system >> The write protection is active >> Unknown storage device

Solution >> Check plug contacts of foot control >> Check the plug contacts of the dongle >> Check the plug contacts of the motor >> Allow motor to cool for at least 10 minutes >> Plug in a USB stick with sufficient memory

WARNING OVERHEATING

>> Switch off the control unit >> Allow the control unit to cool for at least 10 minutes >> Switch on the control unit 49

Error messages Icon Description of error WARNING TIME-OUT SYSTEM ERROR WARNING OSSTELL

Solution >> Release the pedal (grey) on the foot control >> Allow motor to cool for at least 10 minutes > Switch the control unit off and back on again If the error message appears again, contact an authorized W&H service partner immediately. >> Remove the ISQ module and then assembly or >> Connect probe >> Remove probe from a source of electromagnetic interference >> Maintain a distance between the probe and the SmartPeg (3-5 mm) or >> Switch the control unit off and back on again

>> If the described problem cannot be resolved, the unit will need to be inspected by an authorized W&H service partner. >> In case of a total system failure, switch the control unit off and on again. 50