VDW CONNECT Locate Apex Locator Directions For Use Manual

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Directions For Use

ex Locator

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Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

1 Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

2 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

3 Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

4 Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

5 Adverse Reactions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

6 Step by Step Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

6.1 Document Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

6.2 Device Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

6.3 Package Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

6.3.1 Assembling the charger . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

6.4 Modes of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

6.5 Description of the VDW.CONNECT Locate

6.5.1 General overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

6.6 Description of the LED Colors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

6.7 Description of the Sounds . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

6.8 Plugging in the VDW.CONNECT Locate

6.8.1 Plugging in the VDW.CONNECT Locate

mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

6.8.2 Plugging in the VDW.CONNECT Drive

6.9 Testing VDW.CONNECT Locate

Apex Locator Functionality . . . . . . . . . . . . . . . . 25

6.9.1 Closed-loop test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Apex Locator . . . . . . . . . . . . . . . . . . 19

Measurement Cable . . . . . . . . . . . . . . . 23

Measurement Cable in uncombined

Measurement Cable in combined mode . 24

6.9.2 Device test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

6.10 Determining the Working Length . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

6.10.1 Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

6.10.2 Start working length determination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

6.10.3 Working length determination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

6.10.4 Uncombined mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

6.10.5 Combined mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

6.10.6 Interruption of file progression indication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

6.10.7 Tips for successful file progression indication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

6.10.8 Comparison of electronic length determination versus radiography . . . . . . . . . . . . 37

6.11 Stand-by Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

6.12 Battery Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

6.12.1 Battery Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

7 Cleaning, Disinfection and Sterilization . . . . . . . . . . . . . . . . . . . . . . . . . 41

7.1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

7.2 Cleaning Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

7.3 Disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

7.4 Sterilization of the File Clip and Lip Clip . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

8 Technical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

9 VDW.CONNECT Locate® Apex Locator Error Codes . . . . . . . . . . . . . . 49

10 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

11 Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58

12 Disposal of the Product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

13 Identification of Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

13.1 Normative Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

Appendix A: Electromagnetic Emissions and Immunity. . . . . . . . . . . . 61

FOR DENTAL USE ONLY

Introduction

Dear Customer,

Congratulations on your purchase of VDW.CONNECT Locate® Apex Locator.

VDW.CONNECT Locate® Apex Locator is an electronic device for support in working length

determination using endodontic instruments.

It can be used in:

• Uncombined mode (VDW.CONNECT Locate® Apex Locator only);

• Combined mode with VDW.CONNECT Drive

• Connected mode (VDW.CONNECT Locate

VDW.CONNECT® App available for iPad®).

These Directions for Use (DFU) are kept up-to-date by VDW GmbH. The most current version can be accessed at www.vdw-dental.com and is also available from VDW.CONNECT® App. We strongly recommend that you periodically check this website for updates of this DFU.

The DFU is available in other languages upon request. If a printed version in your language is not enclosed, VDW GmbH will send a free copy to any address in Europe. To order a free copy of the DFU, send a request to service@vdw-dental.com.

Some images in the DFU may vary slightly from the actual device. We would appreciate your feedback. If any errors are noted, please contact VDW GmbH Customer Service.

VDW GmbH Bayerwaldstr. 15 81737 Munich Germany

Handpiece;

Apex Locator in wireless communication with

Phone +49 89 62734-0 Fax +49 89 62734-304 service@vdw-dental.com www.vdw-dental.com

1 INDICATIONS FOR USE

VDW.CONNECT Locate® Apex Locator supports the dentist in the determination of the working

length during the endodontic treatment. The use of this product is destined exclusively to duly qualified dental practitioners.

The use of this product by unqualified, or untrained personnel can result in patient injury, personal injury and / or material damage.

Disposable Barrier Sleeves and Covers are intended to serve as a disposable barrier for dental instruments and equipment. VDW.CONNECT Locate® Disposable Barrier Sleeve is non-sterile and intended for single patient use only.

To guarantee the safety, intended functionalities and good maintenance of VDW.CONNECT

Locate® Apex Locator, follow the indications given in the present Directions for Use (DFU). Keep

the DFU updated as per described in the Introduction section. VDW GmbH will not accept any liability if VDW.CONNECT Locate® Apex Locator is used, stored or manipulated outside of the indications given in the DFU.

2 CONTRAINDICATIONS

Read the following contraindications before use.

• Do not use VDW.CONNECT Locate® Apex Locator on patients wearing active implantable

devices such as a heart pacemaker or defibrillator.

• The use of VDW.CONNECT Locate to metals. Check Section 8 Technical Characteristics for a list of materials used.

• Do not use VDW.CONNECT Locate procedure outside endodontics.

• Safety and effectiveness of use have not been established in pregnant or breastfeeding women or in children.

• The end user of the device should use clinical judgment for its proper use.

• Color-blind users must ensure that they always operate the device with the sound ON, and that they are familiar with the various sound signals before using the device for the first time. Check section 6.7 Description of the Sounds before using the device.

• Hearing-impaired users must ensure familiarity with the various visual signals before using the device for the first time. Check section 6.6 Description of the LED Colors before using the device.

• The device is not indicated for users both color-blind and hearing-impaired unless they have these difficulties balanced out.

Apex Locator is not recommended in patients allergic

Apex Locator for implants or any other dental

3 WARNINGS

Read the following warnings before use.

VDW GmbH accepts no liability in the event that any of these warnings are disregarded. Check the outer packaging seal on reception. Do not use the device if the packaging seal has been broken. Contact customer service. Report discrepancies between labeling and packaging, or issues with either, to customer service.

Dental Practitioner

• Read the full DFU before using VDW.CONNECT Locate® Apex Locator on a patient.

Operate VDW.CONNECT Locate safe and effective use.

• Ensure that you have a suitable working distance to see the display from your working position.

• VDW.CONNECT Locate

- Endodontic treatment.

- Use by trained and qualified professionals only, such as:

- dentists in dental practice, and

- dental assistants for cleaning and preparation of the device only, and in accordance with this DFU.

Environmental conditions

• Do not use VDW.CONNECT Locate® Apex Locator in the presence of free oxygen,

anesthetics, flammable substances / gases or in a potentially explosive environment.

• VDW.CONNECT Locate® Apex Locator must be operated and stored in a safe, dry and

clean environment.

• Place VDW.CONNECT Locate

the clamp) or firmly attached to the lab coat (when used with the clamp).

• VDW.CONNECT Locate

locations or near liquids.

• Do not expose VDW.CONNECT Locate® Apex Locator to direct or indirect heat sources.

• Avoid collisions and falls. After a fall, please check that VDW.CONNECT Locate

Locator works properly (refer to section 6.9 Testing VDW.CONNECT Locate

Locator Functionality).

• VDW.CONNECT Locate® Apex Locator contains a Bluetooth® module and may cause radio

interference or disrupt the operation of equipment in its vicinity. If this happens, the

interference should be reduced by reorienting or repositioning VDW.CONNECT Locate Apex Locator or by screening off its immediate environment. For further information refer to

Appendix A: Electromagnetic Emissions and Immunity.

Apex Locator only in accordance with this DFU to ensure

Apex Locator and the VDW.CONNECT® App are intended for:

Apex Locator on a flat and stable surface (if used without

Apex Locator must not be placed on damp surfaces, in damp

Apex

• VDW.CONNECT Locate

Apex Locator requires special precautions with regard to

electromagnetic compatibility (EMC) and must be installed and operated in strict compliance

with the EMC Directive. In particular, VDW.CONNECT Locate

Apex Locator must not be used in the vicinity of fluorescent lamps, radio transmitters, remote controls or portable / mobile RF communication devices, even if they meet CISPR 11 requirements. See

Appendix A: Electromagnetic Emissions and Immunity.

• Make sure cables do not limit mobility during a procedure.

• Do not kink the cables or the charger.

• Do not pull directly on the cables when plugging in or unplugging components. Make sure the cables are not obstructed or have limited mobility.

• Refer also to section 8 Technical Characteristics for general Environmental Conditions specifications.

• Use of VDW.CONNECT Locate

Apex Locator adjacent to, or stacked with other equipment

should be avoided because it could result in improper operation. If such use is necessary,

VDW.CONNECT Locate

Apex Locator and the other equipment should be observed to

verify that they are operating normally.

• Do not expose VDW.CONNECT Locate® Apex Locator to infrasound or ultrasound sources.

During treatment

• Ensure that contact point between file and file clip are kept dry to avoid inaccurate readings.

• Make sure that the VDW.CONNECT Locate

Lip Clip and the VDW.CONNECT Locate®

File Clip do not come into contact with an electric power source such as an electrical socket. This could result in severe electrical shock.

• The cable functionality must be checked with a closed-loop test before each use. See 6.9.1

Closed-loop test.

• If the VDW.CONNECT Locate

File Clip is not properly connected to the endodontic

instrument, VDW.CONNECT Locate® Apex Locator will not provide correct information and the file clip could be damaged.

• Use of gloves and of a rubber dam are mandatory during treatment.

• Do not pour water or any other liquid over VDW.CONNECT Locate

• The use of VDW GmbH VDW.CONNECT Locate

Disposable Barrier Sleeves is required

Apex Locator.

(see section 7 Cleaning, Disinfection and Sterilization). Use only custom barriers provided

by VDW GmbH made specifically for VDW.CONNECT Locate® Apex Locator.

• Always perform an X-ray and set the stopper to the determined working length before using

VDW.CONNECT Locate

Apex Locator.

• Before starting the reading, dry the access cavity with a cotton pellet and ensure that there is no excess of liquid inside the root canal targeted for the treatment. An excess of liquid can hinder the reading process. Take into account that the canal should not be completely dry otherwise no reading will occur. Moisten an extremely dry canal with Glyde™ file prep to help provide a stable reading.

• Before starting the treatment, make sure that the device is in a stable position (over a flat surface or firmly attached to the lab coat if using the clamp) to ensure that the treatment can be done comfortably and that any visual / auditory signals emitted by VDW.CONNECT

Locate

• If any irregularities with VDW.CONNECT Locate

Apex Locator can be received.

Apex Locator should occur during

treatment, switch it off, consult Section 10 Troubleshooting or Contact VDW GmbH Customer Service.

• The scale indication on VDW.CONNECT Locate

Apex Locator and on VDW.CONNECT®

App does not represent a distinct length or distance in [mm] or other linear units. It only indicates an estimated proximity of the file tip to a reference point for working length determination.

• Make sure to use only fully metallic endodontic files whether in combined mode or in uncombined mode.

• Only use undamaged endodontic instruments, meaning the instruments shall be in good condition and within their useful life (as defined by the manufacturer). Please, refer to the information provided by the manufacturer of the instrument.

• An accurate working length determination cannot be made using a damaged

VDW.CONNECT Locate

File Clip.

• Only use original cables and adaptors.

• The following patient-related factors may prevent accurate readings:

- Blocked root canal.

- Teeth with large apices.

- Root fracture or perforation.

- Metal crowns or bridges.

- Endodonic file not matching canal size (canal size much larger than endodontic file size).

• If there is no audible sound or no visible flash of the LEDs when VDW.CONNECT Locate®

Apex Locator is switched on, do not use it.

• Always switch off VDW.CONNECT Locate

• VDW GmbH cannot be held liable if VDW.CONNECT Locate

Apex Locator before cleaning it.

Apex Locator is not installed,

operated and maintained in accordance with the instructions in this DFU. No modifications to

VDW.CONNECT Locate® Apex Locator are allowed, except battery changes (see following

Section).

• Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the

VDW.CONNECT Locate

Apex Locator (IEC 60601-1), including cables specified by VDW

GmbH. Failure to observe this could result in a degradation of the performance of this equipment. For further information, refer to Appendix A: Electromagnetic Emissions and

Immunity.

After Treatment

• Never leave VDW.CONNECT Locate® Lip Clip or VDW.CONNECT Locate® File Clip in

contact with a patient if either of them is not plugged into the measurement cable. This could result in severe electrical shock if they come into contact with an electrical source.

• Follow instructions given in section 7 Cleaning, Disinfection and Sterilization.

Battery

• Always use the original charger with the charging cable to charge VDW.CONNECT Locate®

Apex Locator. Use of non-original chargers may result in serious risk for the safety of the user.

• Regularly check for signs of battery leakage.

• If fluid leaks from VDW.CONNECT Locate

Apex Locator, the battery may be damaged. Stop using the device immediately. If the leakage occurs while charging, disconnect the charger immediately. Avoid skin contact with the leaking fluid and contact the VDW GmbH Customer Service as soon as possible.

• Do not recharge the battery in case of suspected faulty/ leaking battery.

• Do not use batteries past the expiry date (when provided).

• Never use a battery that is deformed, discolored or otherwise abnormal.

• If the batteries do not charge fully after 6 hours, they should be replaced.

• To charge the device, connect the charger to electrical mains compliant with the regulations in each country.

• Be sure to purchase and use only the original battery (part reference M00CLOC2ACBAT).

• Only charge VDW.CONNECT Locate

Apex Locator out of patients reach.

• Only perform VDW.CONNECT Locate® Apex Locator test out of patients reach. Use new gloves to avoid contamination of the external tester.

• Only open VDW.CONNECT Locate

Apex Locator to change the batteries (see section

6.12.1 Battery Replacement). Removing more than the bottom cover of VDW.CONNECT

Locate

Apex Locator voids the warranty. Contact VDW GmbH Customer Service for

assistance.

• Fully charge VDW.CONNECT Locate® Apex Locator prior to its first use (6 hours charging time).

• Always ensure that both VDW.CONNECT Locate

Apex Locator and the iPad® have

sufficient battery charge before starting treatment. At low battery level, VDW.CONNECT

Locate

Apex Locator should not be used. See section 6.12 Battery Care.

• VDW.CONNECT Locate® Apex Locator must not be charged during treatment.

• VDW.CONNECT Locate

Apex Locator with an empty battery will not provide any audio or

visual signals.

Combined mode

• VDW.CONNECT Locate® Apex Locator can be used in combined mode with

VDW.CONNECT Drive

• Only use VDW.CONNECT Drive

Handpiece.

Handpiece for working in combined mode. Using

VDW.CONNECT Locate® Apex Locator with another Handpiece can lead to severe

electrical problems (including electrical shock).

• Only use VDW GmbH accessories and spare parts.

• Do not plug the VDW.CONNECT Locate

original cables into any other devices with

compatible plugs.

• The use of the VDW.CONNECT Drive

Handpiece Sleeve is mandatory to ensure proper functioning of the system in combined mode. The barrier is designed for single use and must be disposed of and changed after each patient.

• Please ensure that you have the latest version of VDW.CONNECT Drive

Handpiece

firmware and of VDW.CONNECT Locate® Apex Locator firmware to work in combined mode.

For further information on VDW.CONNECT Drive® Handpiece Sleeve, please refer to VDW.CONNECT Drive® Handpiece Directions For Use.

Please read VDW.CONNECT Drive® Handpiece Directions For Use - 3 Warnings before using VDW.CONNECT Drive® Handpiece.

Please read VDW.CONNECT® App User Manual - 3 Warnings before using VDW.CONNECT® App.

Accessories

• VDW.CONNECT Locate® Lip Clip and VDW.CONNECT Locate® File Clip are supplied

unsterilized. You must reprocess them prior to first use and between patients (Follow instructions given in section 7 Cleaning, Disinfection and Sterilization).

• Use VDW GmbH components / accessories and spare parts only. Using non-original accessories / spare parts can lead to increased emission of electromagnetic interferences or to reduced electromagnetic interference immunity.

• Examine the state of the connectors before use.

• Never leave VDW.CONNECT Locate

Lip Clip or VDW.CONNECT Locate® File Clip

unplugged to the VDW.CONNECT Locate® Measurement Cable while in contact with a patient.

Repairs and Defects

• Check if VDW.CONNECT Locate® Apex Locator works properly, if it has been subjected to

mechanical shock or impact (e.g. if it has been dropped). Do not use it in case of malfunction, apparent breakage or cracks. The safety and effectiveness of the device can be seriously

compromised. In cases of major shock, VDW.CONNECT Locate

Apex Locator needs to be inspected by authorized technical personnel. Contact VDW GmbH Customer Service for assistance.

• VDW.CONNECT Locate

Apex Locator does not contain user serviceable parts (except

batteries). The service and repair should be provided by factory trained service personnel

only. Therefore, repairs, alterations and modifications to VDW.CONNECT Locate® Apex

Locator are not permitted. VDW GmbH cannot be held liable if VDW.CONNECT Locate

Apex Locator has been altered or modified. If a defect should occur, contact VDW GmbH Customer Service.

• It is mandatory to reprocess VDW.CONNECT Locate

Apex Locator and its accessories

(including cables and tester) before shipping them to the service centre (follow instructions given in section 7 Cleaning, Disinfection and Sterilization).

• Protect VDW.CONNECT Locate

Apex Locator with appropriate packaging when sending it

for service.

Transport

• Intact VDW.CONNECT Locate® Apex Locator can be transported by land freight or airfreight

in the original packaging. The applicable requirements must be met (see table below).

• Defective VDW.CONNECT Locate

Apex Locator with intact battery can also be transported

by airfreight or land freight in the original packaging.

• If the battery is defective (refer to Battery section above to identify defective batteries),

VDW.CONNECT Locate

Apex Locator must not be transported by airfreight under any

circumstances.

Applicable standards and regulations for the transport of VDW.CONNECT Locate® Apex Locator

Intact

VDW.CONNECT

Locate® Apex

Locator or defective

VDW.CONNECT

Locate

Apex Locator with intact battery.

VDW.CONNECT

Locate® Apex

Locator with defective battery.

Electromagnetic emissions and immunity

• HF (high-frequency) surgical equipment can influence the operation of the device and may

not be operated in combination with VDW.CONNECT Locate

• Portable wireless communications equipment such as wireless home network devices, mobile phones, cordless telephones and their base stations, walkie-talkie etc. can affect

VDW.CONNECT Locate

to any part of VDW.CONNECT Locate® Apex Locator.

• The use of accessories, transducers and cables other than those specified, with the exception of transducers and cables sold by the manufacturer of the VDW.CONNECT

Locate

emissions or decreased immunity of the VDW.CONNECT Locate

• Use of VDW.CONNECT Locate® Apex Locator adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary,

VDW.CONNECT Locate

verify that they are operating normally.

Air freight Land freight

• IATA: The batteries are considered “Not restricted” as long as they are shipped in compliance with SP A199.

• UN 3496 NiMH (Nickel-metal hydride) batteries in equipment.

• EU (ADR / RID) Section 3.2 Table A: Batteries, nickel-metal hydride, “Not subject to ADR”.

• EU (ADR / RID) Identified damaged or defective batteries shall be carried in

Not possible.

accordance with especial provision 376 and packaged in accordance with packaging instructions P908 of 4.1.4.1 or LP904 of 4.1.4.3 as applicable.

Apex Locator.

Apex Locator and should be kept at least at a distance of 30 cm

Apex Locator or replacement parts for internal components, may result in increased

Apex Locator and the other equipment should be observed to

Apex Locator.

4 PRECAUTIONS

Read the following precautions before use.

• The manufacturer declines any responsibility in the case of using VDW.CONNECT Locate®

Apex Locator outside of its intended use or indications specified in this DFU. Please refer to sections 1 Indications for Use and 3 Warnings for further information on the indications for use.

• VDW.CONNECT Locate (see Sections 2 Contraindications and 3 Warnings).

• It is mandatory to take preoperative radiographs prior to using VDW.CONNECT Locate Apex Locator and to compare the information given by both methods. In case of clinically relevant discrepancy, it is recommended to take a second radiograph with an endodontic file in place at the selected working length.

Apex Locator may not be able to work properly in all conditions

5 ADVERSE REACTIONS

The use of VDW.CONNECT Locate® Apex Locator is not recommended with patients allergic to metals (see Section 8 Technical Characteristics).

If VDW.CONNECT Locate® Apex Locator provides an incorrect reading and there is no radiographic data to compare to, the following adverse reactions may occur:

• Inadequate root canal treatment due to under- or over-instrumentation.

6 STEP BY STEP INSTRUCTIONS

Refer to the section 3 Warnings to verify any special care to exercise before starting to use the device.

Refer to the section 13 Identification of Symbols to verify the description of all symbols before starting to use the device.

Refer to VDW.CONNECT® App User Manual for all information regarding VDW.CONNECT Locate® Apex Locator connection with VDW.CONNECT® App.

Before use, check the exact contents of the package. See 6.3 Package Contents.

6.1 Document Symbols

Symbol Identification

Consult VDW.CONNECT® App User Manual or VDW.CONNECT Locate® Apex Locator Directions For Use

If the instructions are not followed properly, operation may carry risks for the product or the user / patient

Additional information, explanation on operation and performance

Suggestion or advice

6.2 Device Compatibility

Specification Description

• iPad Mini™ 2

• iPad Mini™ 3

iPad

VDW.CONNECT® App operating system

VDW.CONNECT Drive® Handpiece

*Apple®, the Apple logo, iPad®, iPad Pro® and iPad Mini™ are trademarks of Apple Inc., registered in the U.S. and other countries. App Store

is a service mark of Apple Inc.

• iPad Mini™ 4

• iPad® (6th gen)

• iPad Pro

10.5"

12.9" (2nd gen)

• iOS

• Original VDW GmbH VDW.CONNECT Drive®

Handpiece

6.3 Package Contents

N° Action

Remove carefully the device and the accessories from their packaging and place them on a flat

surface.

Check that VDW.CONNECT Locate® Apex Locator is supplied with all the components shown

below and that all components are in good condition.

List of components with VDW GmbH Stock Keeping Unit

VDW.CONNECT Locate® Apex

Locator M00CLOC000000 (supplied with rechargeable battery M00CLOC2ACBAT)

VDW.CONNECT Locate®

Measurement Cable M00CLOC1ACCBL

VDW.CONNECT Drive®

Measurement Cable M00CLOC1ACHPA

VDW.CONNECT Locate®

External Tester M00CLOC1ACTST (There may be pins attached to the back of the tester depending on the tester version. These pins have no function)

VDW.CONNECT Locate®

Disposable Barrier Sleeve* (x 100) M00CLOC1ACBAR (replacement polyethylene sleeves are supplied separately)

List of components with VDW GmbH Stock Keeping Unit

VDW.CONNECT Locate® Lip

Clip (x 5) M00CLOC5ACLCL

VDW.CONNECT Locate® File

Clip (x 2) M00CLOC2ACFCL

VDW.CONNECT Locate®

Clamp* M00CLOCCLAMP0

AC Adapter Plugs (*EU, *UK, US, *ANZ and universal adapter) M00CLOC1ACCHG

Getting Started Guide(s) / DFU -

*These components are not available in all kits

Optional VDW.CONNECT Locate® Clamp

The device is delivered with an optional clamp (if available in your country), which can be installed on the back of the device with a screw (included in the package). The clamp can be installed with a standard flat / slot drive screwdriver (not included in the package). Remove the grub screw before attaching the clamp.

Components not included

The following components are not included in the kit:

iPad® with iOS operating system.

6.3.1 Assembling the charger

N° Action

A Select the charger plug adapter that matches your power outlet.

B Place the plug adapter into the slots and slide it downwards until it locks with a click.

6.4 Modes of Operation

VDW.CONNECT Locate® Apex Locator can be used in 2 different modes:

Uncombined mode Combined mode

Working only with VDW.CONNECT Locate® Apex Locator.

For cable connection see 6.8.1 Plugging in the

VDW.CONNECT Locate® Measurement Cable in uncombined mode.

Working with VDW.CONNECT Locate® Apex Locator

plugged to VDW.CONNECT Drive

Handpiece for shaping towards the reference point while receiving endodontic file progression information.

VDW.CONNECT Locate

Apex Locator can

be used while VDW.CONNECT Drive® Handpiece motor is rotating.

The use of VDW.CONNECT Drive Handpiece Sleeve is mandatory to ensure the proper functioning of the system in combined mode.

The VDW.CONNECT Drive® Handpiece sleeve supplied in your country may look different from the

VDW.CONNECT Drive

Handpiece sleeve shown on

the illustration

For cable connection see 6.8.2 Plugging in the

VDW.CONNECT Drive® Measurement Cable in combined mode.

On both operating modes, the device can be connected to the VDW.CONNECT® App.

Refer to VDW.CONNECT® App User Manual.

6.5 Description of the VDW.CONNECT Locate® Apex Locator

6.5.1 General overview

Connector for

VDW.CONNECT

Locate®

Measurement

Cable,

VDW.CONNECT

Drive®

Measurement

Cable, charger

cable and external

tester

ON/OFF/Standby button

File progression indication

Screws of battery compartment

Rubber pad

Bluetooth

button

Screw thread

Battery compartment

The screw thread provides the ability to connect a VDW.CONNECT Locate® Clamp. Check with your distributor for more information about the clamp (if not included in the kit). The illustration above might slightly differ from the actual product.

6.6 Description of the LED Colors

Button / LED Function Status Description

All LEDs will light up white for a short period of time at the startup of

VDW.CONNECT Locate

Apex Locator.

VDW.CONNECT Locate® Apex Locator is off.

Device is powering on.

Power status

Device is on.

Stand-by.

LED flashing every 2.5 seconds, with a color corresponding to battery status.

Device is charging.

LED flashing every second.

Device is sufficiently charged.

Enough autonomy for several procedures.

Low battery level.

Battery status

Enough autonomy for approximately 15 minutes.

Very low battery level.

Enough autonomy for approximately 5 minutes. Do not start a new treatment at this battery level.

Critically low battery level.

There is no autonomy left. Please recharge your

VDW.CONNECT Locate

Apex Locator.

Button / LED Function Status Description

Bluetooth® not activated.

Bluetooth® active but device not connected.

Connection of

VDW.CONNECT

Locate® Apex

Locator with the

VDW.CONNECT

App

Device connected to VDW.CONNECT® App.

See VDW.CONNECT® App User Manual - 6 Step by Step Instructions.

Connection lost.

See VDW.CONNECT® App User Manual - 10 Troubleshooting.

Shaping target reverted to default setting 5 minutes after connection loss (if no file progress information was received during that time).

File progress information.

Endodontic file progress information

The color (blue, green flashing, green, red flashing) varies according to the progression of the file in the root canal. See 6.10.3 Working

length determination.

Closed-loop test (See 6.9.1

Closed-loop test)

Closed-loop test is successful.

See 6.9.1 Closed-loop test.

Closed-loop-test failed.

Any indication other than white steady or no indication at all. See 10 Troubleshooting.

Device test is on-going.

Device test

(see 6.9.2 Device

test)

Device test is successful.

The LED is ON until the VDW.CONNECT

Locate® External Tester is unplugged.

Device test failed.

The LED is ON until the VDW.CONNECT

Locate

External Tester is unplugged.

6.7 Description of the Sounds

Sound volume can only be adjusted through the VDW.CONNECT® App.

See VDW.CONNECT® App User Manual - 6 Step by Step Instructions.

Situation Signal

Any button pressed

VDW.CONNECT Locate® External Tester connected

Combination of VDW.CONNECT Locate®

Apex Locator with VDW.CONNECT Drive Handpiece

Device test

Working length determination

• One short beep.

• Two short beeps

• Double beep if VDW.CONNECT Locate® Apex

• No beep if an unknown cable is plugged or if

• Three longer beeps if the combination is lost.

See 6.10.5 Combined mode.

• Double beep when VDW.CONNECT Locate® Apex

• Alternating beeps when VDW.CONNECT Locate

See 6.9.2 Device test.

• Beeping intervals become shorter as endodontic file

• At reference point, continuous tone until apical

• Fast pulsating tones (alarm condition) when file

See 6.10.3 Working length determination.

Locator is correctly combined with VDW.CONNECT

Handpiece.

Drive

VDW.CONNECT Locate

Apex Locator is

incorrectly combined with VDW.CONNECT Drive® Handpiece.

Locator device test is successful.

Apex Locator device test failed.

progresses towards reference point for working length determination.

foramen (major apical foramen/diameter) is passed.

passes the apical foramen.

VDW.CONNECT Drive® Handpiece will rotate in reverse direction when VDW.CONNECT

Locate

Apex Locator is uncombined during a treatment and the Apical Reverse function is

activated.

6.8 Plugging in the VDW.CONNECT Locate® Measurement Cable

6.8.1 Plugging in the VDW.CONNECT Locate® Measurement Cable in uncombined mode

N° Action

Insert VDW.CONNECT Locate® Apex Locator inside its proprietary single use protective sleeve.

Plug in the VDW.CONNECT Locate® Measurement Cable (2) to VDW.CONNECT Locate®

Apex Locator (1).

Connect the VDW.CONNECT Locate® Lip Clip (3) to the VDW.CONNECT Locate®

Measurement Cable (2).

Connect the VDW.CONNECT Locate® File Clip (4) to the VDW.CONNECT Locate®

Measurement Cable (2).

6.8.2 Plugging in the VDW.CONNECT Drive® Measurement Cable in combined mode

N° Action

Only use VDW.CONNECT Drive® Handpiece for working in combined mode. Using

VDW.CONNECT Locate

Apex Locator with another Handpiece can lead to severe electrical

problems (including electrical shock).

Insert VDW.CONNECT Drive® Handpiece inside its proprietary single-use protective sleeve.

The use of the VDW.CONNECT Drive® Handpiece Sleeve is mandatory to avoid contact between the contra-angle and the patient’s mouth, which might cause wrong readings on

VDW.CONNECT Locate

Insert VDW.CONNECT Locate® Apex Locator inside its proprietary single-use protective sleeve.

Plug in the VDW.CONNECT Drive® Measurement Cable (2) to VDW.CONNECT Locate® Apex

Locator (1).

Connect the VDW.CONNECT Locate® Apex Locator Lip Clip (3) to the VDW.CONNECT Drive®

Measurement Cable (2).

Plug in VDW.CONNECT Drive® Handpiece (4) to the VDW.CONNECT Drive® Measurement

Cable (2).

Apex Locator.

For further information on VDW.CONNECT Drive® Handpiece Sleeve, please refer to VDW.CONNECT Drive® Handpiece Directions For Use.

The VDW.CONNECT Drive® Handpiece sleeve supplied in your country may look

different from the VDW.CONNECT Drive

Handpiece sleeve shown on the illustration.

R R

6.9 Testing VDW.CONNECT Locate® Apex Locator Functionality

6.9.1 Closed-loop test

This feature checks the cables. This test should be performed before each treatment.

N° Action

Turn ON VDW.CONNECT Locate® Apex Locator (1).

See 6.6 Description of the LED Colors.

Connect the VDW.CONNECT Locate® or VDW.CONNECT Drive® Measurement Cable (2 or 5)

to VDW.CONNECT Locate

Connect the VDW.CONNECT Locate® Lip Clip (3) and the VDW.CONNECT Locate® File

Clip (4) or VDW.CONNECT Drive

VDW.CONNECT Drive

in the VDW.CONNECT Drive

Make a closed-loop circuit with the VDW.CONNECT Locate® or VDW.CONNECT Drive® Measurement Cable:

Hook the VDW.CONNECT Locate

with the endodontic file inserted in the VDW.CONNECT Drive

VDW.CONNECT Locate

functional.

Any result other than white indicates a test fail.

Apex Locator (1).

Measurement Cable (2 or 5). Ensure that an endodontic file is inserted

Apex Locator (1) central LED will turn white indicating that cables are

Handpiece (6) to the VDW.CONNECT Locate® or

Contra-angle.

File Clip (4) to the lip clip (3) or put the lip clip (3) in contact

Contra-angle (7).

If the closed-loop test failed, please refer to 10 Troubleshooting.

The VDW.CONNECT Drive® Handpiece sleeve supplied in your country may look different from

the VDW.CONNECT Drive shown on the illustration.

Handpiece sleeve

6.9.2 Device test

Use the VDW.CONNECT Locate® External Tester to test the basic functionality of the VDW.CONNECT Locate® Apex Locator. Run this test periodically (e.g. once a week), after the

device has not been used for a long period of time or for troubleshooting reasons (as per Section

10 Troubleshooting).

The VDW.CONNECT® App will guide you through the different steps of the device test.

See VDW.CONNECT® App User Manual - 6 Step by Step Instructions.

N° Action

Turn ON VDW.CONNECT Locate® Apex Locator.

See 6.6 Description of the LED Colors.

Plug the VDW.CONNECT Locate® External Tester (1) in the device (2).

The device test will automatically start. The central LED will flash white and a double beep will be emitted.

If device test is successful:

N° Action

Central LED will light up green and a double beep will be emitted simultaneously.

You can now unplug the VDW.CONNECT Locate® External Tester from VDW.CONNECT

Locate® Apex Locator.

If device test fails:

N° Action

Central LED will light up red and alternating beeps will be emitted simultaneously.

Unplug the VDW.CONNECT Locate® External Tester from VDW.CONNECT Locate® Apex

Locator.

Repeat the above procedure (A to B one more time).

If the error persists DO NOT USE THE DEVICE and contact your VDW GmbH Customer Service.

6.10 Determining the Working Length

6.10.1 Definition

The anatomical terminology is defined as follows:

N° Description

(1) Coronal and medial regions.

(2) Region coronal to the reference point for working length determination.

(3) Reference point for working length determination.

(4) Region beyond reference point.

(5) Apical foramen.

(6) Apical foramen (Major apical foramen or diameter) passed/over-instrumentation.

6.10.2 Start working length determination

As detailed in section 6.4 Modes of Operation, VDW.CONNECT Locate® Apex Locator can work in different modes. Please also refer to Section 3 Warnings.

Regardless of the mode of operation, the following steps and principles apply.

Prior to using VDW.CONNECT Locate® Apex Locator on a patient, the access cavity must be dried with a cotton pellet to prevent an electric short circuit through another canal. However, the canal being treated must be humid to allow electric conduction. Both conditions need to be met to ensure correct file progression information. Moisten an extremely dry canal with Glyde™ file prep to help provide conditions for a stable reading.

Select the size of the file matching the root canal diameter.

Before starting to work with the VDW.CONNECT Locate® File Clip, check if corrosion is visible on the metal part of the hook. In case corrosion is present, use a new file clip (see Section 10

Troubleshooting).

For detailed steps on how to work with VDW.CONNECT Locate® Apex Locator in uncombined and combined modes, refer to sections 6.10.4 Uncombined mode and 6.10.5 Combined mode.

6.10.3 Working length determination

It is mandatory to read carefully Section 3 Warnings before reading this section. Important safety information is contained there.

When working in connected mode, the working length is graphically illustrated in

VDW.CONNECT® App. Please refer to VDW.CONNECT® App User Manual - 6 Step by Step

Instructions.

Color indication on

VDW.CONNECT Locate

Apex Locator

Endodontic file progression

Coronal and medial regions:

Move the endodontic file apically.

LED: Solid blue. Sound: Slow pulsating tone.

Color indication on

VDW.CONNECT Locate®

Apex Locator

Endodontic file progression

Audio signals (from the device) serve as indication of the file tip progression towards reference point. The interval between the beeps becomes shorter when the endodontic file approaches the reference point for working length determination.

Region coronal to the reference point for working length determination:

The endodontic file can be moved further apically.

LED: Flashing green. Sound: Fast pulsating tone.

Reference point for working length determination:

This is the relevant position to determine the working length.

LED: Solid green. Sound: Solid tone.

In combined mode, the Apical Reverse function can be activated. Refer to

VDW.CONNECT

App User Manual – 6 Step by Step Instructions.

The position of the reference point can be adjusted with the “Shaping Target”

function, which is only available when VDW.CONNECT Locate

Apex Locator

is connected to the VDW.CONNECT® App. Refer to the VDW.CONNECT® App User Manual for instructions on that function.

Region beyond reference point:

Further file progression beyond the reference point is visualized.

LED: Solid green. Sound: Solid tone.

Color indication on

VDW.CONNECT Locate®

Apex Locator

Endodontic file progression

Apical foramen (Major apical foramen or diameter) passed / overinstrumentation.

Alarm condition:

LED: Flashing red. Sound: Fast pulsating tones.

Potential harm to the patient can be caused when this region is reached.

6.10.4 Uncombined mode

If you have an iPad® and you prefer to work in connected mode, see VDW.CONNECT® App User Manual.

The following step-by-step instructions refer to the uncombined use (without VDW.CONNECT Drive® Handpiece).

Ensure that a rubber dam/dental dam is securely placed before you start endodontic treatment.

Avoid touching the device with contaminated gloves to prevent contamination near the connector or underneath the clamp.

N° Action

After reprocessing of VDW.CONNECT Locate® Apex Locator and its accessories (see Section 7

Cleaning, Disinfection and Sterilization), place VDW.CONNECT Locate

single-use VDW.CONNECT Locate

Disposable Barrier Sleeve, with the long end of the barrier

Apex Locator in a

sleeve at the top. If you are using the optional VDW.CONNECT Locate® Clamp on the back of the device, pull a second sleeve over the clamp as follows:

Press the ON/OFF/Standby button on VDW.CONNECT Locate® Apex Locator (1).

Connect the VDW.CONNECT Locate® Measurement Cable (2) to the device (1).

Connect the VDW.CONNECT Locate® Lip Clip (3) to the VDW.CONNECT Locate®

Measurement cable (2).

Connect the VDW.CONNECT Locate® File Clip (4) to the VDW.CONNECT Locate®

Measurement Cable (2).

F Perform a closed-loop test. See 6.9.1 Closed-loop test.

G Put the lip clip (3) on the patient’s lip on the opposite site of the tooth to be treated.

Insert the endodontic file (5) into the root canal and attach the file clip (4) to the metallic part of

the endodontic file (5) directly below the plastic handle and above the stopper (6).

Move the endodontic file apically until reference point (default reference point or reference point

defined as per Shaping Target function) is reached.

J Set the silicon stopper at the coronal reference.

Remove the endodontic file from the root canal and use an external ruler to measure the distance

between the tip of the endodontic file and the silicon stopper. This information will be relevant for subsequent files in your sequence.

Compare this distance information with the corresponding information given by pre-treatment

radiographs.

Proceed with endodontic treatment. Carefully monitor file progression to avoid over-

instrumentation.

Please note that the mandatory rubber dam is not shown in the schematic image below, for clarity’s sake.

6.10.5 Combined mode

If you own VDW.CONNECT Drive® Handpiece, you can operate VDW.CONNECT Locate® Apex Locator in combined mode for simultaneous canal shaping and file progression monitoring.

It is mandatory to read carefully Section 3 Warnings before reading this section. Important safety information is contained there.

The use of VDW.CONNECT Drive® Handpiece Sleeve is mandatory to ensure the correct

functioning of VDW.CONNECT Locate Ensure that a rubber dam/dental dam is securely placed before starting endodontic treatment. Always establish the working length manually (radiographically and/or using uncombined mode) before starting an endodontic treatment in combined mode. Avoid touching the device with contaminated gloves to prevent contamination near the connector or underneath the clamp.

Please refer to VDW.CONNECT Drive® Handpiece Directions For Use for its use and specific hygiene measures.

N° Action

Apex Locator in combined mode.

After reprocessing of VDW.CONNECT Locate® Apex Locator and its accessories (see Section 7

Cleaning, Disinfection and Sterilization), place VDW.CONNECT Locate

single-use VDW.CONNECT Locate® Disposable Barrier Sleeve, with the long end of the barrier

sleeve at the top. If the optional VDW.CONNECT Locate

VDW.CONNECT Locate

Disposable Barrier Sleeve over the clamp as illustrated in Section

Clamp is used, pull a second

Apex Locator in a

6.10.4 Uncombined mode.

Press the ON/OFF/Standby button on VDW.CONNECT Locate® Apex Locator (1).

Connect the VDW.CONNECT Drive® Measurement Cable (2) to the device (1).

Connect the VDW.CONNECT Locate® Lip Clip (3) to the VDW.CONNECT Drive® Measurement

Cable (2).

Put a VDW.CONNECT Drive® Handpiece single-use barrier (8) over the Handpiece (5) to isolate

it.

Plug the VDW.CONNECT Drive® Measurement Cable (4) into the Handpiece (5) and insert an

endodontic file (7) into the VDW.CONNECT Drive

Contra-angle (6).

G Perform a closed-loop test. See 6.9.1 Closed-loop test.

Put the VDW.CONNECT Locate® Lip Clip (3) on the patient’s lip on the opposite side of the tooth

to be treated.

Move the endodontic file apically until reference point (default reference point or reference point

defined as per Shaping Target function) is reached.

Proceed with endodontic treatment. Carefully monitor file progression to avoid over-

instrumentation.

In combined mode, you can use the Apical Reverse function. This function is only available when

the VDW.CONNECT Drive

to the VDW.CONNECT

Handpiece is connected to the VDW.CONNECT® App. Please refer

App User Manual for description of that function.

Please note that the mandatory rubber dam is not shown in the schematic image below, for clarity’s sake. The Handpiece sleeve supplied in your country may look different from the Handpiece sleeve shown on the illustration.

6.10.6 Interruption of file progression indication

During the treatment, the VDW.CONNECT Locate® File Clip may be disconnected from the endodontic file and reconnected at any time (e.g. when the file is changed to a larger size or when the length of another canal should be determined).

6.10.7 Tips for successful file progression indication

Implausible, rapidly changing indications from VDW.CONNECT Locate® Apex Locator may have various causes. Should you experience either situation, please review the below checklist to identify possible causes and take appropriate actions.

Issue Solution

Excess liquid in the pulp chamber or root canal (i.e. rinsing solution, blood or saliva) creating wrong conductive path and incorrect length determination.

Gingival proliferation can lead to direct contact with the endodontic file causing a short circuit and incorrect length determination.

The endodontic file contacting metallic dental restorations (crown, intracanal, amalgam filling) may cause a short circuit and incorrect length determination.

No rubber dam or no VDW.CONNECT Drive® Handpiece Sleeve is used. This may cause a distortion of the electrical signal for the reading.

Dry the access cavity with a cotton pellet / air-blower. Wait until any bleeding has stopped.

Isolate the access cavity by:

• Adequate preparation filling;

• Placing a dental dam;

• Electro-cauterizing.

Carefully enlarge the access cavity and isolate with flow composite. Widen carefully the opening at the top of the crown.

Use a rubber dam and the VDW.CONNECT Drive® Handpiece Sleeve.

If the device indications change too slowly, please review the following check-list:

Issue Solution

Blocked root canal impeding the conductive path and preventing normal device functioning.

Retreatment: blockage by old canal filling material residue, impeding the conductive path and preventing normal device functioning.

Blockage by remnants of a medicated substance (e.g. calcium hydroxide) impeding the conductive path and preventing normal device functioning.

Extremely dry root canal impeding the conductive path and preventing normal device functioning.

Special condition symptom: exceptionally large apical foramen due to lesion or incomplete formation.

Root fracture or perforation.

Check the comparative radiographs for support information on canal length; Catheterize with ISO 06 / 08 endodontic file until the working length is reached.

Take a radiograph to re-check and try to completely remove the old canal filling material prior to determining length.

Completely remove the remnants prior to determining length.

Rinse root canal with irrigating solution such as NaCl or NaOCl and dry the access cavity with a cotton pellet / airblower.

May lead to incorrect feedback from VDW.CONNECT

Locate

May lead to incorrect feedback from VDW.CONNECT

Locate® Apex Locator. Perform radiography.

Apex Locator. Perform radiography.

6.10.8 Comparison of electronic length determination versus radiography

Radiography represents a two-dimensional projection of a three-dimensional root canal system. There are some cases when the radiographic length and the electronic length do not match. In case of discrepancy, please refer to GCP standards applicable in your country as well as your clinical expertise.

6.11 Stand-by Mode

When VDW.CONNECT Locate® Apex Locator is not used for a certain period of time, it enters stand-by mode as described below.

Mode LED description Wake-up action

Device active

Stand-by mode

Shut-down

(inactive for 20 min)

ON/OFF/Standby LED emits a color corresponding to the battery status.

ON/OFF/Standby LED flashes and emits a color corresponding to the battery status.

Bluetooth

and Central LEDs are turned

OFF.

None.

(VDW.CONNECT Locate® Apex Locator ready to be used).

Start using VDW.CONNECT

Locate® Apex Locator.

Press the ON/OFF/Standby button.

All LEDs are turned OFF.

6.12 Battery Care

It is recommended to read Section 3 Warnings (Battery) before reading this section. Important safety information is located there.

VDW.CONNECT Locate® Apex Locator is powered by two AAA (1.2 V) Ni-MH batteries. During

the operation, the battery status is shown on the device front panel as the color of the ON/OFF/ Standby button. See 6.6 Description of the LED Colors.

The following notes will help you to ensure the battery provides a long service life:

• If the battery LED on the device flashes red, there is less than 5 min of device autonomy left.

You must charge the device.

• Do not charge the battery more than once a day. It is recommended that you charge the

device at the end of each day.

• Charge the battery overnight after using VDW.CONNECT Locate

battery is fully charged after up to 6 hours of charging.

• Always fully charge the battery, i.e. until the battery LED stops flashing green and turns

steady green.

• When the charger is unplugged, the device will go in active mode.

• When the device is in standby mode and the charger is plugged, the device will start

charging.

• When the device is turned off and the charger is plugged, the device will start charging.

N° Action

A Connect the charger (2) to the device (1) and plug it into the power outlet.

Apex Locator. The

6.12.1 Battery Replacement

It is recommended to read section 3 Warnings (Battery) before reading this section. Important safety information is located there.

Before replacing the battery, disconnect the charger from the device. Then switch the device OFF.

Always replace the batteries with two new batteries if they cannot be recharged correctly. The old batteries must be disposed of in accordance with local regulations.

Fully charge the batteries before first use. Only use VDW GmbH batteries (part reference M00CLOC2ACBAT).

The battery compartment is located at the rear of VDW.CONNECT Locate® Apex Locator and its cover is secured by two 6-lobe screws (screw type: KN6041; screwdriver type: Torx T5).

N° Action

A Using an Torx T5 screwdriver, unscrew the two screws (1) and remove the battery cover (2).

B Remove the two batteries (3) from the battery compartment (4).

C Insert two new batteries, replace the battery cover (2) and screw the two screws (1).

In order to avoid ingress of liquids during reprocessing procedures, make sure that after closing the battery compartment no gaps are visible in the housing between the battery cover and the lower housing.

7 CLEANING, DISINFECTION AND STERILIZATION

7.1 General

You must consult the special VDW.CONNECT Locate® Cleaning, Disinfection and Sterilization Guide before proceeding with cleaning disinfection and sterilization.

Disposable (single-use) VDW.CONNECT Locate® Barrier Sleeves do not replace reprocessing of dental equipment / accessories or endodontic instruments. Always reprocess VDW.CONNECT

Locate® Apex Locator.

The following parts shall be reprocessed before and after each treatment.

The reprocessing procedure might damage the (USB) plugs connected to the VDW.CONNECT

Locate® Apex Locator / VDW.CONNECT Drive® Handpiece ports. They are unlikely to be

contaminated during normal (plugged) use. Avoid reprocessing these plugs.

Part Reprocessing steps

• VDW.CONNECT Locate® Apex Locator

• VDW.CONNECT Locate® Measurement Cable

• VDW.CONNECT Drive

Measurement Cable

Clean and disinfect.

Do not sterilize.

• VDW.CONNECT Locate® File Clip

• VDW.CONNECT Locate® Lip Clip

VDW GmbH accepts no liability in the event that these instructions are disregarded or unvalidated processes are used to reprocess the accessories.

Use only properly maintained equipment and approved materials according to national laws and/ or regulations.

Always wear protective clothes for your own safety (gloves, mask, glasses and a waterproof gown) for the reprocessing process.

Clean, Disinfect and Sterilize.

7.2 Cleaning Procedure

Cleaning is intended to remove all the visible soiling (e.g. organic and inorganic) from the surface of the device and accessories so that the subsequent disinfection process can be efficient.

N° Cleaning steps

VDW.CONNECT Locate® Apex Locator (and clamp, if used), VDW.CONNECT Locate®

Measurement Cable and VDW.CONNECT Drive

Switch off VDW.CONNECT Locate® Apex Locator, then remove and discard the

single-use VDW.CONNECT Locate® Disposable Barrier Sleeve (sleeves if the

VDW.CONNECT Locate

Pay attention that no liquid enters the device connecting port, e.g. by keeping the cable plugged-in.

Clean the devices by using a single-use wipe or soft cloth soaked in cleaning fluid

containing Alcohol Quaternary Ammonium active ingredients (e.g. CaviWipes™ or CaviCide™).

For the VDW.CONNECT Locate® Apex Locator, clean the grooves and device screws by using a clean brush with soft bristle (e.g. nylon) slightly soaked in cleaning

solution containing Alcohol Quaternary Ammonium active ingredients (e.g. CaviWipes™ or CaviCides™).

Continue steps B and C until no debris appear on the wipe / brush. Replace the wipe

and clean the brush as necessary.

VDW.CONNECT Locate® File Clip and Lip Clip

Pre-treatment of the file clip and lip clip – for personal protection

After use, place the file clip and lip clip directly into a dish filled with a suitable cleaning and disinfection solution (Cidezyme, Johnson & Johnson Medical, 0.8% for

at least 1 minute, maximum 2 hours) for cleaning, pre-disinfection and interim storage. Make sure that the devices are fully immersed.

clamp is used).

Measurement Cable

N° Cleaning steps

Use clean, soft brushes or a clean, soft cloth or single-use wipe to remove

contamination and remnants manually. Do not use metal brushes or wire wool.

Squeeze the VDW.CONNECT Locate® File Clip open and release it 5 times during cleaning to allow the inner parts to be cleaned effectively. Note that disinfectant used

for pre-treatment is only for personal protection and does not obviate the need for disinfection once cleaning has been completed. Pre-treatment should never be omitted.

Rinse the devices under flowing sterile, deionized water at least 3 times for 1 minute

each time, in order to remove all visible traces of contamination and remnants.

Check that no visible contamination or remnants remain, and repeat E – H if

necessary. Replace the wipe and clean the brush when necessary.

Cleaning of the file clip and lip clip – Cleaning and ultrasonic bath

Place the pre-treated VDW.CONNECT Locate® File Clip and Lip Clip into the

cleaning bath for the prescribed contact time (e.g. CIDEZYME Detergent Solutions, Johnson & Johnson Medical, 0.8% for 1 minute); make sure

that the devices are fully immersed (if necessary, use a soft brush to make sure they

, ENZOL® Enzymatic

remain fully immersed). Squeeze the file clip open and release it 5 times during cleaning to allow the inner parts to be cleaned effectively.

Remove the devices from the cleaning bath and rinse them thoroughly at least 3

times for 1 minute each time with sterile, deionized water; while rinsing, squeeze the file clip open and release it 5 times.

Place the devices in an ultrasonic bath with a cleaning agent (e.g. CIDEZYME®,

ENZOL® Enzymatic Detergent Solutions, Johnson & Johnson Medical, 0.8% for

20 minutes); make sure that the devices are fully immersed (if necessary, use a soft brush to make sure they remain fully immersed). Squeeze the file clip open and release it 5 times during cleaning to allow the inner parts to be cleaned effectively.

Then, remove the devices from the ultrasonic bath and rinse them thoroughly at least

3 times for 1 minute each time with sterile, deionized water; while rinsing, squeeze the file clip open and release it 5 times.

7.3 Disinfection

Disinfection shall be done immediately after cleaning using the following procedure:

N° Disinfection steps

VDW.CONNECT Locate® Apex Locator (and clamp, if used), VDW.CONNECT Locate®

Measurement Cable and VDW.CONNECT Drive

Measurement Cable

Disinfect the surface of devices paying special attention to grooves and screws (and clamp, if used). Pay attention that no disinfectant enters the VDW.CONNECT

Locate

Apex Locator connector, e.g. by having the cable plugged-in. Use a single-

use wipe or soft clean cloth lightly soaked in disinfectant containing Alcohol Quaternary Ammonium active ingredients (e.g. CaviWipes™ or CaviCide™).

Remove all disinfectant residue. No visible impurities or liquid should remain on the

devices after disinfection.

Insert VDW.CONNECT Locate® Apex Locator in a new and unused single-use

VDW.CONNECT Locate

Disposable Barrier Sleeve before starting the next

treatment.

If the device is not being used immediately after the reprocessing process, keep it in

a safe and clean environment and follow the instructions for storage and transport.

VDW.CONNECT Locate® File Clip and Lip Clip

Once the devices have been cleaned and inspected, place them into the disinfection bath for the prescribed contact time (Cidex OPA, Johnson & Johnson Medical, 100%

for 20 minutes); the devices must be fully immersed in the solution. Squeeze the file clip open and release it 5 times during disinfection to allow the inner parts to be disinfected effectively.

Remove the devices from the disinfection bath and rinse them off thoroughly at least

5 times for 1 minute each time with water; when you rinse them, squeeze the file clip open and release it 5 times.

Dry the file clip and lip clip with oil-free, filtered compressed air and leave them to dry

further in a clean place for at least 20 minutes.

Once the devices are dry, inspect them to ensure they are clean, dry and

undamaged.

Use only disinfectants containing Alcohol Quaternary Ammonium active ingredients (e.g.

CaviWipes™ or CaviCides™), except for the VDW.CONNECT Locate

File Clip and Lip Clip

(see above). Use only approved disinfectants compatible with the device and accessories (see 8

Technical Characteristics).

Leave the disinfectant to act in accordance to manufacturer’s instructions. Avoid leaving the disinfectant in contact with the device surfaces for a time longer than that recommended by the manufacturer of the disinfectant product. It can result in damage to the device.

7.4 Sterilization of the File Clip and Lip Clip

The sterilization process applies only to the lip clip and file clip. The maximum number of sterilization cycles is:

• File clip: 120;

• Lip clip: 120.

Proceed with the sterilization as follows:

N° Sterilization steps for file clip and lip clip

Pack and seal accessories into single-use, undamaged sterilization packaging (single-layer packaging) that complies with the following requirements:

• DIN EN ISO / ANSI AAMI ISO 11607;

• Suitable for steam sterilization (withstands temperatures of up to 142 °C or more, sufficient vapor permeability).

Sterilize the file clip and lip clip by Pre-Vacuum Displacement (3 times pre-vacuum < 60 mbar).

• At 134 °C for 3 minutes, drying time 20min.

Please note:

• Do not exceed a sterilization temperature of 135°C and a sterilization duration of 18min;

• Always observe the operating instructions of the manufacturer for your sterilizer, especially about the loading weight, the operating time and functional testing;

• Use steam sterilizers in accordance with DIN EN 13060 or DIN EN 285, ANSI / AAMI ST 79.

Inspect the file clip and the lip clip before use after they have been reprocessed. If visible signs of moisture are present (damp spots on sterile packaging, pooled water in the load) at the end of the sterilization cycle, repackage and re-sterilize using a longer drying time. Dispose of any

defective accessories immediately. If the press-release mechanism of the file clip does not function properly, repeat the complete reprocessing procedure. Discard the file clip if the pressrelease mechanism does not work properly.

The sterilization process must be validated in accordance with DIN EN ISO 17665 (valid installation and operational qualification (IQ and OQ) and product-specific performance qualification (PQ)).

8 TECHNICAL CHARACTERISTICS

Specification Description

VDW GmbH Bayerwaldstr. 15 81737 Munich Germany

Manufacturer

Phone +49 89 62734-0 Fax +49 89 62734-304 service@vdw-dental.com www.vdw-dental.com

Model

Dimensions

Cable length

Weight 80 g (0.18 lbs)

Material

VDW.CONNECT Locate® Apex Locator

Length: 75 mm Width: 46 mm Height: 20 mm

• Charger cable: 2 m

• VDW.CONNECT Locate

Measurement Cables: 1.3 m

• VDW.CONNECT Locate

User control panel: Polyester PVS-F

Housing: ABS plastic

Cables: TPE, silicone, TPV

VDW.CONNECT Locate® File Clip:

Glass filled nylon

VDW.CONNECT Locate® Lip Clip:

Stainless steel Screws: Stainless steel

Single use VDW.CONNECT Locate® Disposable Barrier Sleeve: Polyethylene

VDW.CONNECT Locate® Clamp:

Stainless steel Rubber pad: SEBS

Threaded insert: brass

Grub screw: stainless steel A1

and VDW.CONNECT Drive®

File clip FCA: 0.15 m

Specification Description

Rechargeable 2x AAA Ni-MH Batteries:

Power supply

Minimum capacity 750 mAh

1.2 VDC nominal; INTERNALLY POWERED DEVICE

• Power supply:

• Frequency:

Charger (type: FW7662M/05)

• Nominal power output:

• Electrical safety class:

Applied part

BF (VDW.CONNECT Locate® File Clip and VDW.CONNECT

Locate

Protection against water ingress IP 20

Safety level in the presence of flammable anesthetic gas mixtures or oxygen

Not suitable for use in the presence of flammable anesthetic gas mixtures or oxygen

• Use: in enclosed spaces

• Ambient temperature:

Ambient conditions

• Relative humidity:< 80%;

• Operating altitude:

• Maximum housing temperature according to IEC 60601-

• Ambient temperature:

• Relative humidity:

Conditions for transport and storage

• Pressure:

• Do not subject VDW.CONNECT Locate

• Not to use or store system in a flammable environment

100 - 240 VAC

50 - 60 Hz

5.5 VA

Class II

Lip Clip)

15°C - 35°C (59°F - 95°F)

non-condensing at 0°C (32°F)

< 2 000 m (approximately 6561 ft) above sea level

1/A1:2012

-20°C - +50°C (-4°F - 122°F)

20% - 80%, non-condensing at > 40°C (104°F)

50 kPa - 106 kPa

Apex Locator to temperature shock. Let it warm up to room temperature for 24h after bringing it from a cold to a warmer environment.

Specification Description

• iPad Mini™ 2

Mini™ 3

Mini™ 4

10.5''

12.9'' (2nd gen)

App User Manual

iPad

VDW.CONNECT® App Operating System

EMC Tables

• iPad

• iPad® (6th gen)

• iPad Pro

• iOS

• Refer to VDW.CONNECT

See Appendix A: Electromagnetic Emissions and

Immunity

Mode of Operation Continuous (Ref. IEC 60601-1:2005 + A1:2012)

VDW.CONNECT Locate® Apex Locator Device: 3 years

Expected Service Life

Handpiece Adapter, Measurement Cables: 6 months File Clip and Lip Clip: 120 sterilization cycles

Essential Performance

This equipment does not have Essential Performance (Ref. IEC 60601-1:2005 + A1:2012)

Medical Device Class Class IIa, Rule 10, according to MDD 93/42/EEC (Annex IX)

9 VDW.CONNECT LOCATE® APEX LOCATOR ERROR

CODES

If a failure occurs on VDW.CONNECT Locate® Apex Locator, the nature of the failure is given by a combination of colors and sounds as described in the following table.

State Failure Solution

Charge VDW.CONNECT Locate® Apex Locator

Sound: Audio signal

Critical / Device unrecoverable

Device warning recoverable

(see 6.12 Battery Care).

It the problem persists, return the instrument to your service center.

Connect to VDW.CONNECT® App for further information / instructions.

See VDW.CONNECT® App User Manual - 6 Step by Step instructions.

Sound: triple beep

Sound: off

Sound: triple beep

Empty battery

Bluetooth® module failure

Charge VDW.CONNECT Locate® Apex Locator (see 6.12 Battery Care).

Connect to VDW.CONNECT® App for further information / instructions.

See VDW.CONNECT® App User Manual - 6 Step by Step instructions.

State Failure Solution

Sound: triple beep

Battery charge not sufficient to perform a firmware upgrade

General firmware failure

LED failure

Connect to VDW.CONNECT® App for further information / instructions.

See VDW.CONNECT

App User Manual - 6 Step by

Step instructions.

Connect to VDW.CONNECT® App for further information / instructions.

See VDW.CONNECT

App User Manual - 6 Step by

Step instructions.

If NONE of the LEDs lights up in white color during boot-up and a triple beep sound is heard, there is a LED failure.

Return the instrument to your service center.

10 TROUBLESHOOTING

If VDW.CONNECT Locate® Apex Locator is not operating properly, check the possible cause using the following checklist. If you are unable to solve the problem by referring to the checklist, contact VDW GmbH Customer Service.

Also refer to the error codes, which may be indicated on VDW.CONNECT Locate® Apex Locator, as described in section 9 VDW.CONNECT Locate® Apex Locator Error Codes.

Refer to VDW.CONNECT Drive® Directions For Use for any troubleshooting related to VDW.CONNECT Drive® Handpiece in combined mode.

Refer to VDW.CONNECT® App User Manual for any troubleshooting related to Bluetooth connection.

VDW GmbH requires that you reprocess the product before shipping it to a service center.

To remedy certain problems, it is necessary to perform a factory reset (delete user settings and restore factory settings) on the device. In such case proceed as described below.

To perform a factory reset:

N° Key Action

Hold down the ON/OFF/Standby button for approximately 20 seconds.

B Release the ON/OFF/Standby button.

The factory reset takes 20 seconds in total. After the first 10 seconds, there is a brief white flash of all LEDs. At the end of the process, another white flash and a long beep indicate a successful factory reset.

VDW.CONNECT Locate® Apex Locator does not switch on or it shuts off during treatment.

Possible causes Solutions

• The battery is completely empty (all LEDs are OFF).

• The charger is not connected properly into the power socket.

• The battery is wrongly inserted.

• The original battery has been replaced with a non-original one.

• ON/OFF/Standby button malfunction. • Try pressing the ON/OFF/Standby button

• Electronic malfunction. • Perform a factory reset.

• Connect the device to the charger and charge the device.

• Ensure that the charger is plugged in correctly and the power socket is under tension/switched ON (if applicable).

• Ensure that the original adapter is being used.

• Open the battery compartment and check the battery orientation.

several times.

• Replace the batteries with a new original battery.

• Contact VDW GmbH Customer Service.

• Send the device to VDW GmbH Customer Service.

No feedback from VDW.CONNECT Locate® Apex Locator during treatment.

Possible causes Solutions

• The battery is completely empty (all LEDs are OFF).

• The cables are damaged or not connected correctly.

• Non-original cables are used.

• Connect the device to the charger and charge the device.

• Ensure that original cables have been used.

• Ensure that the cables are undamaged and connected correctly.

• Perform closed-loop to test to check functionality of cables and device test to check functionality of device.

• If in combined mode, ensure that the original

VDW.CONNECT Drive

used.

• If in combined mode, ensure that the endodontic file has been correctly inserted into the

VDW.CONNECT Drive

• Clean the lip clip and the file clip according to the procedure.

• If all else fails. • Perform a factory reset.

If cables are damaged or if the ClosedLoop test fails after a second attempt,

DO NOT USE VDW.CONNECT Locate Apex Locator with the damaged cables and contact your VDW GmbH Customer Service.

Contra-angle is being

Contra-angle.

• If requested to send the device and/or components to VDW GmbH Customer Service, reprocess the device, file clip, lip clip and cables before sending them back to customer services (Refer to Section 7 Cleaning, Disinfection and

Sterilization).

No sound or no light signal emitted during treatment.

Possible causes Solutions

• The battery is completely empty (all LEDs are OFF).

• Connect the device to the charger and charge the device.

• Electronic malfunction. • Perform a factory reset.

• Send the device to VDW GmbH Customer Service.

Endodontic file progression indication is unstable or frozen.

Possible causes Solutions

• Calcified or obliterated root canal.

• Extremely dry root canal.

• Old root filling residues creating a blockage due to insufficient removal of intra-canal medicament (i.e. calcium hydroxide).

• Check comparative X-rays for more information

and repeat reading on VDW.CONNECT

Locate® Apex Locator to verify the result.

• Rinse with NaOCl solution. Dry access cavity with cotton ball / air blow.

• Do a comparative X-ray, and fully remove old gutta-percha / intra-canal medicament.

• Endodontic file too narrow for large root canal.

• Large lateral canal.

• Select a larger endodontic file.

• Block the external conductive path.

• Deep caries provide a conductive path outside the canal.

• Perforation.

• VDW.CONNECT Locate® Lip Clip incorrectly attached to patient mouth. Insufficient contact between the lip clip and the oral mucosa.

• Endodontic file incorrectly connected to the file clip (i.e. connected to the metal shaft).

• Soiled VDW.CONNECT Locate

File Clip.

• Place the lip clip in the patient mouth and ensure a good contact between the mucosa and lip clip (place the lip clip in the labial angle opposite to the tooth to be treated).

• Ensure that the endodontic file and the file clip are properly in contact with each other.

• Perform a closed-loop test.

• Clean the file clip according to the reprocessing instructions in 7 Cleaning, Disinfection and

Sterilization.

• Defective connection cable. • Check cables and sockets for visible damage and ensure the connections are correct.

• Perform a closed-loop test to test cable functionality.

• LEDs damaged or not working properly.

• Electronic malfunction.

• Perform a factory reset.

• Contact VDW GmbH Customer Service.

Endodontic file progression indication is too sensitive (i.e. it displays the relevant position for working length determination too quickly).

Possible causes Solutions

• Short-circuit due to excess fluid in the pulp chamber (rinsing solution, saliva, blood).

• Dry the access cavity using an air blower or a cotton ball. In case of excess bleeding wait until it has stopped.

• If heavy bleeding is observed, wait until bleeding has been successfully stopped.

• Direct contact between endodontic file and gingiva / gingival proliferation (i.e. in cases with fractured metal crowns).

• Direct contact between endodontic file and metal restoration work (crowns, parapulpal pins; amalgam fillings).

• For isolation:

- Adequate tooth build-up;

- Crown lengthening;

- Electro-cauterisation.

• Use a dental dam. Isolate the endodontic file by placing 2-3 silicone stoppers on it or insert the endodontic file in a small polyvinyl tube before use.

• Use the protective VDW.CONNECT Drive® Handpiece Sleeve on the VDW.CONNECT

Handpiece (if in combined mode).

Drive

The use of VDW.CONNECT Drive Handpiece Sleeve on the

VDW.CONNECT Drive

Handpiece (when working in combined mode) is mandatory to ensure the correct functioning of the system in combined mode.

• Lateral root canal.

• Immature canal with large apex.

• Carefully widen the access cavity. If necessary add flow composites to isolate.

• Repeat length determination process.

Battery does not recharge when the power supply is connected (the battery LED remains OFF when power supply is connected).

Possible causes Solutions

• Bad charger connection.

• Power socket is not under tension/ switched off

• Disconnect the charger from the device and reconnect it again.

(if applicable).

• Charger malfunction. • Replace the charger with an original charger.

• Electronic malfunction. • Contact VDW GmbH Customer Service.

Device test and quick closed-loop test do not start.

Possible causes Solutions

• VDW.CONNECT Locate® External tester is not

working properly.

• Perform a factory reset.

• Contact VDW GmbH Customer Service.

• Electronic malfunction.

VDW.CONNECT Drive® Handpiece undetected in combined mode.

Possible causes Solutions

• VDW.CONNECT Drive® Measurement Cable or

one of the connectors are damaged.

• Check the connection of the cable between

VDW.CONNECT Locate

VDW.CONNECT Drive

Apex Locator and the

Handpiece.

• Perform a closed- loop test in combined mode.

• Firmware of the VDW.CONNECT Drive®

Handpiece not up to date.

• Check if VDW.CONNECT Drive® Handpiece firmware is the latest version available (updated

for VDW.CONNECT Locate

Apex Locator

feature).

• Electronic malfunction. • Perform a factory reset.

• Contact VDW GmbH Customer Service.

Apical Reverse function cannot be switched on.

Possible causes Solutions

• No connection between VDW.CONNECT

Locate® Apex Locator and VDW.CONNECT

Handpiece.

Drive

• Wrong cable connection.

• Cable or connector damaged.

• VDW.CONNECT Drive

Handpiece not

connected to VDW.CONNECT® App.

• Ensure proper connection of the cables between

VDW.CONNECT Locate® Apex Locator and the

VDW.CONNECT Drive

• Ensure that all cables are original and undamaged.

• Connect VDW.CONNECT Drive

VDW.CONNECT® App to benefit from Apical

Reverse function.

• Firmware of VDW.CONNECT Drive® Handpiece

not up to date.

• Ensure that VDW.CONNECT Drive® Handpiece firmware is the latest version available (updated

for VDW.CONNECT Locate feature).

• Apical Reverse setting on the VDW.CONNECT®

App accidentally set to OFF.

• Switch ON the feature on the VDW.CONNECT® App and retry.

• Electronic malfunction. • Perform a factory reset.

• Contact VDW GmbH Customer Service.

VDW.CONNECT Locate® Apex Locator is overheating.

Handpiece.

Handpiece to

Apex Locator

Possible causes Solutions

• Electronic malfunction.

• VDW.CONNECT Locate

overheated and it has switched off.

Apex Locator has

• Allow the device to cool down and start again.

• Check for possible leakage from

VDW.CONNECT Locate

from defective battery). In case of suspected leakage, refer to Section 3 Warnings.

Apex Locator (liquids

11 WARRANTY

VDW GmbH offers customers the following product warranty:

• VDW GmbH guarantees proper manufacturing of the product, the use of top quality materials, performance of all required tests and compliance with to all applicable relevant laws and regulations relating to the product. The full functionality of VDW.CONNECT

Locate® Apex Locator is covered by a 12-month warranty. Cables, accessories and battery

are covered by a 6-month warranty. Warranty period begins on the date of equipment purchase. The customer is only entitled to warranty services within the warranty period and under the condition that VDW GmbH has been informed of the defect within a one-month period from the date of discovery of the defect.

Component Warranty period

VDW.CONNECT Locate® Apex Locator unit

VDW.CONNECT Locate® Charger

VDW.CONNECT Locate® Lip Clip

VDW.CONNECT Locate® File Clip

VDW.CONNECT Locate® External tester

VDW.CONNECT Locate® Measurement Cable

VDW.CONNECT Drive® Measurement Cable

VDW.CONNECT Locate® Clamp

• This warranty covers only the exchange or repair of individual components or parts affected by manufacturing defects. The cost for personnel to be dispatched for purposes of technical assistance from the dealer to the customer, and /or packaging expenses of the customer will not be covered by VDW GmbH. Any customer claims beyond the realm of repair, such as claims for damages, will not be covered. This warranty does not include any compensation for direct or indirect personal injuries or material damage of any kind. The customer will not be entitled to damages covering downtime of the equipment.

• The warranty does not extend to damage for which evidence can be provided by VDW GmbH that such damage has been caused by negligence on the part of the user as related to Directions For Use, particularly during battery charging or battery replacement. The warranty explicitly excludes any defects arising on the basis of:

- damage occurring during transportation to VDW GmbH for the purposes of repair;

- damage occurring through environmental events such as lightning strikes, fire and / or humidity. This warranty shall automatically become cancelled and void if the product has been improperly repaired, modified or manipulated in any manner by the user, by non-authorized persons or by third party personnel.

• Legal claims, such as under product liability law remain unaffected.

12 months

6 months

12 DISPOSAL OF THE PRODUCT

Comply with your national and regional regulations, guidelines and requirements for the disposal of end-of-life electrical equipment and batteries.

Make sure the product or battery are not mixed with other types of waste when being disposed of.

Prior to disassembly and disposal, your device must not be contaminated and must have been completely reprocessed (Refer to Section 7 Cleaning, Disinfection and Sterilization).

13 IDENTIFICATION OF SYMBOLS

13.1 Normative Symbols

Symbol Identification

Serial number

Batch code

Catalogue number

Refer to Instruction Manual / Booklet

Consult Instructions for Use

Electronic Instructions for Use (relevant information for use of the product is available in electronic format from vdw-dental.com).

Manufacturer

Date of manufacture

Class II equipment

Type BF applied part

Direct current (connection for power supply)

Alternating current

䢵

䢶

Symbol Identification

Sterilizable in a steam sterilizer (autoclave) at temperature specified

Opened packages are not replaced

Temperature limit

Humidity limitation

Keep dry

Fragile; handle with care

Accessory

Use by date

xxx

Do not steam sterilize

Do not re-use

Caution

Bluetooth

Plastic

Non-sterile

CE Mark

0123

Recycling: PLEASE DO NOT THROW AWAY! This product and all its components must absolutely be recycled through your distributor

Appendix A: ELECTROMAGNETIC EMISSIONS AND IMMUNITY

Refer to the section 3 Warnings to verify any special care to exercise before starting to use the device.

EMC (general)

VDW.CONNECT Locate® Apex Locator is to be used in a dental practice, in a hospital or a private

practice.

VDW.CONNECT Locate® Apex Locator is EMC-tested in conformity with the requirements of IEC

60601-1-2:2007 3rd (see the following tables) and IEC 60601-1-2:2014 4th Edition (according to clause 7 and 8.9, tables 4 to 9). VDW.CONNECT Locate® Apex Locator is a medical device that requires special safety precautions and must be installed and placed in operation in accordance with the below EMC information.

Compliant Cables and Accessories

The use of accessories and cables other than specified by the manufacturer may result in increased emissions or decreased immunity of this product.

Information about charger

The charger must be used while the VDW.CONNECT Locate® Apex Locator is in charging mode only. VDW.CONNECT Locate® Apex Locator cannot be used for treatments when charging.

The charger for VDW.CONNECT Locate® Apex Locator complies with all relevant standards for battery charger devices.

Information about radio communications

• Bluetooth® LE 4.0 Communication.

• Frequency band: 2.400 to 2.4835 GHz.

• The effective radiated power is below 10 mW.

• Europe: EU EN 300 328 V2.1.1.

This device complies with part 15C of the FCC:

Operation is subject to the following two conditions:

• This device may not cause harmful interference;

• This device must accept any interference received, including interference that may cause undesired operation of the device.

This Class B digital apparatus complies with Canadian ICES-0003.

Compliance with Emission and Immunity Standard

This section provides guidance on compliance to Edition 3 (2007) and 4 (2014) of standard IEC 60601-1-2. Please refer to the relevant subsection according to the applicable regulation in your territory

Compliance to IEC 60601-1-2:2007

Guidance and manufacturer’s declaration - electromagnetic emissions

VDW.CONNECT Locate® Apex Locator is intended for use in the electromagnetic environment specified

below. The customer or the user of VDW.CONNECT Locate such an environment.

Emission test Compliance Electromagnetic environment - guidance

RF Emissions CISPR 11

Harmonic Emissions IEC 61000-3-2

Voltage fluctuations / flicker emissions IEC 61000-3-3

Group 1

Class B

Not applicable

VDW.CONNECT Locate® Apex Locator uses RF energy

only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

VDW.CONNECT Locate® Apex Locator is suitable for use

in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Apex Locator should ensure that it is used in

The following tables are guidelines according to the 3rd edition of the medical standard IEC 60601-1-2.

Guidance and manufacturer's declaration - electromagnetic immunity

VDW.CONNECT Locate® Apex Locator is intended for use in the electromagnetic environment specified

below. The customer or the user of VDW.CONNECT Locate

Apex Locator should ensure that it is used in

such an environment.

Immunity test

standard

Electrostatic discharge (ESD) IEC 61000-4-2

Electrical fast transient / burst IEC 61000-4-4

Surge IEC 61000-4-5

IEC 60601 test level Compliance level

± 6 kV contact ± 8 kV air

± 2 kV for power supply lines ± 1 kV for input / output lines

± 1 kV line(s) to Line(s)mode ± 2 kV line(s) to earth

± 8 kV contact ± 15 kV air

± 2 kV for power supply lines Not applicable (no input/ output lines)

± 1 kV differential mode Not applicable (no earth)

Electromagnetic environment -

guidance

Mains power quality should be that of a typical commercial or hospital environment.

0% UT

(> 95% dip in UT) for 0.5 < 5% UT (> 95% dip in UT) for 0.5 cycle

cycle

(at 0, 45, 90, 135,

180, 225 and 315°

phase angle)

Voltage dips, short interruptions and voltage variations on power supply lines IEC 61000-4-11

< 40% UT (60% dip in UT) for 5 cycles

70% UT (30% dip in UT) for 25 cycles.

0% UT

(> 95% dip in UT) for 1

cycle

(at 0 phase angle)

70% UT

(30% dip in UT) for 25/30

cycles (at 0 phase angle)

Mains power quality should be that of a typical commercial or hospital environment.

< 5% UT (> 95% dip in UT) for 5 s

0% UT

(> 95% dip in UT) for

250/300 cycles (at 0

phase angle)

Power frequency (50 / 60 Hz) magnetic field IEC 61000-4-8

Conducted RF IEC 61000-4-6

Radiated RF IEC 61000-4-3

3 A/m 30 A/m

3 Vrms 150 kHz to 80 MHz

3 V/m 80 MHz to 2.5 GHz

3 Vrms 150 kHz to 80 MHz

3 V/m 80 MHz to 2.7 GHz

Power frequency magnetic fields should be at levels characteristic of a location in a typical commercial or hospital environment.

Portable and mobile RF communications equipment should be used no closer to any part of the VDW.CONNECT

Locate® Apex Locator, including

cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance

d 1.2 P=

150 kHz to 80 MHz

d 1.2 P=

80 MHz to 800 MHz

d 2.3 P=

800 MHz to 2.5 GHz

Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).

Field strengths from fixed RF transmitters, as determined by

an electromagnetic site survey, should be less than the compliance level in each

frequency range.

Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

a Field strengths from fixed transmitters, such as base stations for radio (cellular /cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the

VDW.CONNECT Locate® Apex Locator is used exceeds the applicable RF compliance level above, the

VDW.CONNECT Locate

Apex Locator should be observed to verify normal operation. If abnormal

performance is observed, additional measures may be necessary, such as re-orienting or relocating the

VDW.CONNECT Locate

Apex Locator.

b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Recommended separation distances between portable and mobile RF communications equipment and the

VDW.CONNECT Locate® Apex Locator

The VDW.CONNECT Locate® Apex Locator is intended for use in the electromagnetic environment in

which radiated RF disturbances are controlled. The customer or the user of the VDW.CONNECT Locate

Apex Locator can help prevent electromagnetic interference by maintaining a minimum distance between

portable and mobile RF communications equipment (transmitters) and the VDW.CONNECT Locate® Apex Locator as recommended below, according to the maximum output power of the communication equipment.

Rated maximum

output power of

transmitter

(W)

150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz

d 1.2 P= d 1.2 P= d 2.3 P=

Separation distance according to frequency of transmitter

(m)

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73

1 1.2 1.2 2.3

10 3.8 3.8 7.3

100 12.0 12.0 23.0

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Note 3: An additional factor of 10/3 is used in calculating the recommended separation distance to decrease the likelihood that mobile / portable communications equipment could cause interference if it is inadvertently brought into patient areas.

Compliance with IEC 60601-1-2:2014

Use of VDW.CONNECT Locate® Apex Locator adjacent to, or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary,

VDW.CONNECT Locate

that they are operating normally.

WARNING: Portable RF communication equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm from any part of VDW.CONNECT

Locate® Apex Locator. Otherwise, degradation of the performance of this equipment could result.

VDW.CONNECT Locate® Apex Locator does not have Essential Performance.

Guidance and manufacturer’s declaration - electromagnetic emissions

VDW.CONNECT Locate® Apex Locator is intended for use in the electromagnetic environment specified

below. The customer or the user of VDW.CONNECT Locate® Apex Locator should ensure that it is used in such an environment.

Emission test Compliance Electromagnetic environment - guidance

RF Emissions CISPR 11

Harmonic Emissions IEC 61000-3-2

Voltage fluctuations / flicker emissions IEC 61000-3-3

Group 1

Class B

Not applicable -

Apex Locator and the other equipment should be observed to verify

VDW.CONNECT Locate® Apex Locator generates and

uses conductively coupled radio-frequency energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

VDW.CONNECT Locate® Apex Locator is suitable for use

in establishments directly connected to low voltage power supply network which supplies buildings used for domestic purposes.

Professional healthcare facility environment.

Enclosure port

BASIC EMC

IMMUNITY TEST LEVELS

PHENOMENON

STANDARD OR TEST

METHOD

PROFESSIONAL

HEALTHCARE FACILITY

TEST RESULTS

ENVIRONMENT

Electrostatic Discharge

Radiated RF EM

fields

IEC 61000-4-2

IEC 61000-4-3

± 8 kV CONTACT ± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV AIR

3 V/m

80 MHz - 2,7 GHz

80% AM AT 1 kHz

Pass

Proximity fields from RF wireless communications

IEC 61000-4-3

SEE 8.10. OF REFERENCE STANDARD IEC 61000-4-3

Pass

equipment

RATED power frequency magnetic

d) e)

fields

IEC 61000-4-8

30 A/m 50 Hz OR 60 Hz

Pass

a) The interface between the PATIENT physiological signal simulation, if used, and the ME EQUIPMENT or ME SYSTEM shall be located within 0,1 m of the vertical plane of the uniform field area in one orientation of the ME EQUIPMENT or ME SYSTEM. b) ME EQUIPMENT and ME SYSTEMS that intentionally receive RF electromagnetic energy for the purpose of their operation shall be tested at the frequency of reception. Testing may be performed at other modulation frequencies identified by the RISK MANAGEMENT PROCESS. This test assesses the BASIC SAFETY and ESSENTIAL PERFORMANCE of an intentional receiver when an ambient signal is in the passband. It is understood that the receiver might not achieve normal reception during the test. c) Testing may be performed at other modulation frequencies identified by the RISK MANAGEMENT PROCESS. d) Applies only to ME EQUIPMENT and ME SYSTEMS with magnetically sensitive components or circuitry. e) During the test, the ME EQUIPMENT or ME SYSTEM may be powered at any NOMINAL input voltage, but with the same frequency as the test signal (see Table 1). f) Before modulation is applied. g) This test level assumes a minimum distance between the ME EQUIPMENT or ME SYSTEM and sources of power frequency magnetic field of at least 15 cm. If the RISK ANALYSIS shows that the ME EQUIPMENT or ME SYSTEM will be used closer than 15 cm to sources of power frequency magnetic field, the IMMUNITY TEST LEVEL shall be adjusted as appropriate for the minimum expected distance.

Input a.c. power port

PHENOMENON

Electrical fast transients / bursts

a) l) o)

a) b) j) o)

Surges Line-to-line

a) b) j) k) o)

Surges Line-to-ground

Conducted disturbances induced

by RF fields

Voltage dips

c) d) o)

f) p) r)

Voltage interruptions

f) i) o) r)

BASIC EMC

IMMUNITY TEST LEVELS

STANDARD OR TEST

METHOD

PROFESSIONAL

HEALTHCARE FACILITY

ENVIRONMENT

IEC 61000-4-4

± 2 kV 100 kHz repetition frequency

Pass

IEC 61000-4-5 ± 0.5 kV, ±1 kV Pass

IEC 61000-4-5 ± 0.5 kV, ± 1 kV, ± 2 kV Pass

3 V

0.15 MHz - 80 MHz

IEC 61000-4-6

IEC 61000-4-11

in ISM bands between

6 V

0.15 MHz and 80 MHz

80% AM at 1 kHz

0% UT; 0.5 cycle

At 0°, 45°, 90°, 135°, 180°,

225°, 270° and 315°

Pass

0% UT; 1 cycle and

70% UT; 25/30 cycles

Pass

Single phase: at 0°

IEC 61000-4-11 Pass

TEST RESULTS

a) The test may be performed at any one power input voltage within the ME EQUIPMENT or ME SYSTEM RATED voltage range. If the ME EQUIPMENT or ME SYSTEM is tested at one power input voltage, it is not necessary to re-test at additional voltages. b) All ME EQUIPMENT and ME SYSTEM cables are attached during the test. c) Calibration for current injection clamps shall be performed in a 150 Ω system. d) If the frequency stepping skips over an ISM or amateur band, as applicable, an additional test frequency shall be used in the ISM or amateur radio band. This applies to each ISM and amateur radio band within the specified frequency range. e) Testing may be performed at other modulation frequencies identified by the RISK MANAGEMENT PROCESS. f) ME EQUIPMENT and ME SYSTEMS with a d.c. power input intended for use with a.c.-to-d.c. converters shall be tested using a converter that meets the specifications of the MANUFACTURER of the ME EQUIPMENT or ME SYSTEM. The IMMUNITY TEST LEVELS are applied to the a.c. power input of the converter. g) Applicable only to ME EQUIPMENT and ME SYSTEMS connected to single-phase a.c. mains. h) E.g. 10/12 means 10 periods at 50 Hz or 12 periods at 60 Hz. i) ME EQUIPMENT and ME SYSTEMS with RATED input current greater than 16 A / phase shall be interrupted once for 250/300 cycles at any angle and at all phases at the same time (if applicable). ME EQUIPMENT and ME SYSTEMS with battery backup shall resume line power operation after the test. For ME EQUIPMENT and ME SYSTEMS with RATED input current not exceeding 16 A, all phases shall be interrupted simultaneously. j) ME EQUIPMENT and ME SYSTEMS that do not have a surge protection device in the primary power circuit may be tested only at ± 2 kV line(s) to earth and ± 1 kV line(s) to line(s). k) Not applicable to CLASS II ME EQUIPMENT and ME SYSTEMS. l) Direct coupling shall be used. m) r.m.s., before modulation is applied. n) The ISM (industrial, scientific and medical) bands between 0,15 MHz and 80 MHz are 6,765 MHz to 6,795 MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz. The amateur radio bands between 0,15 MHz and 80 MHz are 1,8 MHz to 2,0 MHz, 3,5 MHz to 4,0 MHz, 5,3 MHz to 5,4 MHz, 7 MHz to 7,3 MHz, 10,1 MHz to 10,15 MHz, 14 MHz to 14,2 MHz, 18,07 MHz to 18,17 MHz, 21,0 MHz to 21,4 MHz, 24,89 MHz to 24,99 MHz, 28,0 MHz to 29,7 MHz and 50,0 MHz to 54,0 MHz. o) Applicable to ME EQUIPMENT and ME SYSTEMS with RATED input current less than or equal to 16 A / phase and ME EQUIPMENT and ME SYSTEMS with RATED input current greater than 16 A / phase. p) Applicable to ME EQUIPMENT and ME SYSTEMS with RATED input current less than or equal to 16 A / phase. q) At some phase angles, applying this test to ME EQUIPMENT with transformer mains power input might cause an overcurrent protection device to open. This can occur due to magnetic flux saturation of the transformer core after the voltage dip. If this occurs, the ME EQUIPMENT or ME SYSTEM shall provide BASIC SAFETY during and after the test. r) For ME EQUIPMENT and ME SYSTEMS that have multiple voltage settings or auto ranging voltage capability, the test shall be performed at the minimum and maximum RATED input voltage. ME EQUIPMENT and ME SYSTEMS with a RATED input voltage range of less than 25 % of the highest RATED input voltage shall be tested at one RATED input voltage within the range. See Table 1 Note c) for examples calculations.

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VDW GmbH Bayerwaldstr. 15 81737 Munich Germany service@vdw-dental.com www.vdw-dental.com

M EN CLOC DFU MAS

Rev.03/19.09.2018

VDW CONNECT Locate Apex Locator Directions For Use Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

Table of contents

1 INDICATIONS FOR USE

2 CONTRAINDICATIONS

3 WARNINGS

4 PRECAUTIONS

5 ADVERSE REACTIONS

6 STEP BY STEP INSTRUCTIONS

6.1 Document Symbols

6.2 Device Compatibility

6.3 Package Contents

6.3.1 Assembling the charger

6.4 Modes of Operation

6.5 Description of the VDW.CONNECT Locate® Apex Locator

6.5.1 General overview

6.6 Description of the LED Colors

6.7 Description of the Sounds

6.8 Plugging in the VDW.CONNECT Locate® Measurement Cable

6.8.1 Plugging in the VDW.CONNECT Locate® Measurement Cable in uncombined mode

6.8.2 Plugging in the VDW.CONNECT Drive® Measurement Cable in combined mode

6.9 Testing VDW.CONNECT Locate® Apex Locator Functionality

6.9.1 Closed-loop test

6.9.2 Device test

6.10 Determining the Working Length

6.10.1 Definition

6.10.2 Start working length determination

6.10.3 Working length determination

6.10.4 Uncombined mode

6.10.5 Combined mode

6.10.6 Interruption of file progression indication

6.10.7 Tips for successful file progression indication

6.10.8 Comparison of electronic length determination versus radiography

6.11 Stand-by Mode

6.12 Battery Care

6.12.1 Battery Replacement

7 CLEANING, DISINFECTION AND STERILIZATION

7.1 General

7.2 Cleaning Procedure

7.3 Disinfection

7.4 Sterilization of the File Clip and Lip Clip

8 TECHNICAL CHARACTERISTICS

10 TROUBLESHOOTING

11 WARRANTY

12 DISPOSAL OF THE PRODUCT

13 IDENTIFICATION OF SYMBOLS

13.1 Normative Symbols