Product Name: Endo Motor and Apex Locator Unit

Model: EMATE-TEC，E-MATE MAX

Basic UDI-DI： 69705149108EAAE

EMDN Code：

• Z121101-INSTRUMENTS FOR DENTAL TREATMENT UNITS,：

• Z121190 - VARIOUS DENTAL STOMATOLOGY INSTRUMENTS

Intended Use:

Endo Motor and Apex Locator Unit with EMATE-TEC is a cordless endodontic treatment

motorized handpiece with root canal measurement capability. It can be used for preparation and

enlargement of root canals, or measuring the canal length. And it can be used to enlarge the

canals while monitoring the position of the file tip inside the canal.

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

3 Do not directly or indirectly place this device near heat source. Operate and store this device in reliable environment.

4 This device requires special precautions regarding electromagnetic compatibility (EMC) and must be in strict accordance with the EMC information for installation and use. Do not use this equipment especially in the vicinity of fluorescent lamps, radio transmitting devices, remote control devices, handheld and mobile high frequency communication devices.

5 Long time use of Reciprocating Motion Mode may result in motor handpiece overheat, thus it should be left to cool for use. If the motor handpiece is overheated frequently, please contact local distributor.

6 Please use the original contra angle. Otherwise it will not be used or cause adverse consequences.

7 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.

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

9 The motor handpiece cannot be autoclaved. Use disinfectant of neutral pH value or ethyl alcohol to wipe its surface.

10 Before the contra angle stopping rotating, do not press the push cover of contra angle. Otherwise the contra angle will be broken.

11 Before the motor handpiece stopping rotating, do not remove the contra angle. Otherwise the contra angle and the gear inside motor handpiece will be broken.

12 Please confirm whether the file is well installed and locked before starting the motor handpiece.

13 Please set torque and speed as per the recommended specification of file manufacturer.

14 Error in replacing lithium batteries can lead to unacceptable risks, so use the original lithium battery and replace the lithium battery according to the correct steps in the instructions.

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

16 Please remove the battery if the motor handpiece is not likely to be used for some time.

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.

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.

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

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.