Product Name: Apex Locator

Model: APEX-S，APEX-D

Basic UDI-DI： 69705149108APAY

EMDN Code：

• Z121190 - VARIOUS DENTAL STOMATOLOGY INSTRUMENTS

Intended Use:

Apex Locator is a microprocessor-controlled device used for locating the apex of the root canal. It determines the position of the file tip inside the root canal by measuring the ratio of the impedance at two frequencies (400 Hz and 8 kHz) and by displaying the progression of the file towards the apical foramen during endodontic treatment.

The device is a reusable, battery-powered, hand-held measuring unit used with the original measuring wire, file clip, lip hook and touch probe, and with the original power adapter supplied by the manufacturer.

Intended users and Environment of Use

Intended Patient Populations

Medical Indications

Periodontitis

Contraindications

It is not intended for use on patients wearing pacemakers or ICDs (Implantable Cardioverter-Defibrillators).

Warnings

1 Please carefully read this Instruction Manual before first operation.

2 This device should be operated by professional and qualified dentist in qualified hospital or clinic.

3 The device must not be placed in humid surroundings or anywhere where it can come into contact with any type of liquids.

4 Do not expose the device to direct or indirect heat sources. The device is not suitable for being used or stored in the presence of a flammable anaesthetic mixture with air, with oxygen or with nitrous oxide.

5 This device requires special precautions regarding electromagnetic compatibility (EMC) and must be installed and operated in strict compliance with the EMC guidelines. Do not use the device in the vicinity of fluorescent lamps, radio transmitters, remote controls or portable and mobile RF communication devices, and do not expose it to high temperatures during charging, operation or storage.

6 Gloves and a rubber dam are compulsory during treatment.

7 This product may be affected by the strong magnetic field generated by MRI, diathermy and electrocautery equipment. Do not use this device in or near an environment that has such equipment, as this could result in inaccurate readings or device failure.

8 Use of this equipment adjacent to or stacked with other equipment should be avoided, as it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.

9 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 device, including the cables specified by the manufacturer.

10 If any irregularities occur with the device during treatment, switch it off and contact the distributor or the manufacturer.

11 Never open or repair the device yourself, as doing so will void the warranty.

12 A risk of fire or electric shock exists where the device shows damaged cables, exposure of electrical parts to water, battery malfunction, or is used with unsupported devices. In such cases the device must not be used.

13 Please use original components; components made by other companies may cause inaccurate measurement or make measurement impossible.

14 Please do not make any changes to the device. Any changes may violate safety regulations, causing harm to the patient. There will be no promises of any modification.

15 Please use the original power adapter. Other power adapter will result in damage to the lithium battery and to the control circuit.

16 Not to position equipment to make it difficult to operate the disconnection device.

17 Do not clean, service or perform any maintenance on any part of the equipment while a patient is connected. Always disconnect the patient from the equipment before carrying out any cleaning, disinfection or maintenance procedures.

18 The file clip, lip hook and touch probe are reusable and must be sterilised under high pressure and high temperature before and after each operation.

19 This device produces electromagnetic interference. Patients or dentists fitted with a cardiac pacemaker must not use this device, and the device is susceptible to other devices which produce electromagnetic interference; dentists should be cautious about operating under such an environment.

20 The device automatically shuts down after 8 minutes without operation.

Precautions

Charge the device for more than 4 hours before using the product for the first time.

Please use original components, the components made by other companies may cause inaccurate measurement or un-measurable.

Please recharge the battery when battery is very low.

Do not use the device while charging.

Do not change the battery, only trained technician or distributor can change the battery. The electronic parts will be damaged if use a wrong battery or install with a wrong way.

Battery is rechargeable, unnecessary to replace batteries repeatedly. Disposal of waste batteries in accordance with local regulations.

The file clip, lip hook and touch probe must be cleaned and sterilised before use and after each patient use; the main unit, the measuring wire and the adapter must be cleaned and disinfected before use and after each patient use.

Perform the function test of the device and of the measuring wire before each use, and carry out the accuracy test with the tester regularly (recommended every one to two weeks).

The reading “0.0” corresponds to the anatomical (major) apical foramen, not to the physiological apical foramen; in clinical practice the working length is determined by subtracting 0.5 to 1.0 mm from the measured value.

The scale indication on the display does not represent a distinct length or distance in mm or in any other linear unit; it indicates the progression of the file towards the apex.

The mouth should be kept dry before and during measurement, and contact between the endo file or the file clip and other metal or instruments must be avoided.

Measurement cannot be performed unless the plug of the measuring wire is completely inserted.

Adverse Reactions / Undesirable side effects

None

Device service life

5. years

Manufacturer Information

Manufacturer Name: Shenzhen Denco Medical Co., Ltd

Manufacturer Address: Room 3108, Block 6, Tian’an Cloud Park, Bantian street, Longgang District, Shenzhen, 518129 Guangdong P.R. China

Factory Address: Room 101, 201, 301B, 401, 701&801, Block 5, Renluo 6 Road No. 6, Shuikou Street, Huicheng District, Huizhou, 516000 Guangdong, P.R. China

Single Registration Number (SRN) of Manufacturer: CN-MF-000014271

Tel.: 86 755 23764065 / Fax.: 86 755 23764065

Website: www.dencoendo.com

Notified Body Information

• Notified Body Name: TÜV Rheinland LGA Products GmbH

• Address: Tillystraße 2, 90431, Nürnberg, Germany

• Notified Body Number: 0197

Authorized representative (AR) Information

• Authorized representative Name: Share Info GmbH

• AR’s Address: Am Schulzentrum 12, 41564 Kaarst, Germany

• Single Registration Number (SRN) of AR: DE-AR-000005132

• This device is supplied with paper instructions for use. Please carefully read the instructions before use.