Product Introduction
The characteristics of this device include:
a) Equipped with a color LCD screen, the image is clear, and multiple colors clearly indicate the trajectory of the file in the root canal;
b) Based on multi frequency independent network measurement technology, automatic calibration ensures measurement accuracy;
c) File clips and lip hooks can be disinfected under high-temperature and high-pressure to avoid cross infection;
d) The battery is rechargeable and does not need to be replaced repeatedly.
e) Foldable for easy adjustment of viewing angle.
Scope of Application
Used to assist in determining the working length of root canals for various types of teeth during dental clinical root canal treatment.
Contraindication
If you encounter patients who are equipped with an implanted pacemaker (or other electrical equipment) and are warned not to use small household appliances such as electric shavers, hair dryers, etc., it is recommended not to use this product.
Equipment Safety Classification
1 Classification by type of electric shock prevention: Class ll equipment with intemal power supply.
2 Classification based on degree of electic shock prevention: BF type application part.
3 Degree of protection against liquid ingress: Ordinary equipment (IPXO).
4 Equipment that cannot be used in the presence of flammable anesthetic gas mixed with air or lammable anesthetic gas mixed with oxygen or nitrous oxide.
5 Classification by operating mode: Continuous operating equipment.
Main Technical Parameters:
1 Battery: 3.7V/ 800 mAh
2 Power adapter:～100V-240V 1A Max 50Hz/60Hz
3 Power consumption:≤0.5W
4 Display: 4.8 inch LCD screen
5 Sound prompt: When the file is close to the root tip, there will be a beep prompt.
6 Operating Environment:
a) Environmental temperature range:+5°C~+40 ℃
b) Relative humidity range: 30%~75%
c) Atmospheric pressure: 70kPa~106kPa
Packing List
Host*1
Measuring wire*1
file clamp*1
lip hook*2
power adapter*1
User manual*1
certificate*1
FDA Statement
The sale of this item may be subject to regulation by the U.S. Food and Drug Administration and state and local regulatory agencies.
If so, you can bid on this item only if you are an authorized purchaser.
If the item is subject to FDA regulation, I will verify your status as an authorized purchaser of this item before shipping of the item.
510(K) Number: K163414
Regulation Number: 872.4850
Product Code: ELC
El 18-sep-2023 a las 15:44:37 CEST, el vendedor añadió los siguientes datos: