Model : CV-215-I

A new advanced cordless LED curing light.

It can provide the maximum light intensity safely and consistently.

Features:

- With the high intensity of 2,200 mW/cm

- Wave length Range : 390nm ~ 470nm

- Full coverage for all optical meterials

- Aviation-grade metal body for better heat dissipation

- Wireless fast charging mode with indicator

- Provide light intensity test for secure use

- Three modes for option . P1(1~3s) P2(5~20s)P3(10-20s)

- Automatic power off, low battery alert

Principle and usage:

CV-215-I adopts the principle of ray radiation light-sensitive resin by shooting at it in a short time.

Technical specifications:

Dimensions: 25mm x 224 mm

Net weight: 193 g

Power source:

1.Power supply: rechargeable Lithium battery

2.Battery mode: ICR 18490

3.Battery voltage and capacity: 3. 7V/2000mA

Battery has protection against Over-voltage, over-current and short circuit

Power Input: AC 100V-240V, 50HZ/60Hz

Input Power: IOVA

Power Output: DC5V/IA

Light source:

1.10w high power blue light LED

2.Checking method: the LED light is fine when the light is on during correctly

3.The wave length of this product can match with the clinical dental resin solidification, such as 3M, Dentsply etc

4.Wave length: 380nm-470nm

Light intensity: 1600 mW/cm2-2200mW/cm

Working condition:

1 Environment temperature: +10C to +40C

2 Relative humidity: 30%-75%

3 Atmosphere pressure: 70kPa to106kPa

Equipment safety

1.Operating mode: intermittent operation

2.Protection type against electrical shock: class II

3.Protection degree against electrical shock: type B

4.Protection against harmful ingress of water or particular matter: rdinary equipment(IPXO)

5.Safety in the presence of flammable anesthetic mixture with air, oxygen or nitrous oxide: not suitable under this condition

Install and uninstall way:

1.The top of the unit can be turned 360 degrees to both left and right

while it is forbidden to remove

2.When the battery needs to be charged, connect the plug of the adapter into the AC100V--240V power supply. Then connect the output plug of the adapter to the DC 5 0V input plug of the pedestal, then put the main unit into the pedestal

Operation:

Press the mode button. Following two modes are available

1. Long press P/T button can exchange PI and P2 mode. when it shows P1 01, tap button to P1 03, Long press to model P2 (5S,10S,15S,20S)

2 During the operation, put the disposable sleeve on the top of the main unit, aim the top at the correct position, press the ON/OFF button and the main unit will produce"Bi"sound, the curing light radiates blue light and starts working according to the set modes. Meanwhile, it starts counting down and will produce tone at every 5 seconds, it stops working when counting down to 0

3 During operation, the blue light can be stopped by press the power button at any time

4 After a working cycle, operator can press the ON/OFF switch to start another working cycle. Stop operating if the equipment began to heat obviously, do not restart until the equipment cool down. Sugges continues working cycle less than 10 times

5 Low power detective circuit is fixed inside of the main unit, when low power is detected, the display screen of main unit will wink, please charge in time

6 When the battery needs to be charged, connect the plug of the adapter into the AC100V-240V power supply. Then connect the output plug of the adapter to the DC 5.0V input plug of the pedestal, and then the logo turn to blue. Put the main unit to the charging point of the pedestal the display screen turn to scrolling display, and the curing lights starts charging

7 After operating, take off the disposable sleeve and throw away, forbidden to reuse

8 This equipment will turn off automatically if don t any action within 2 minutes, turn it on by press any button

9 The depth of solidification of composite is no less than 2mm per I second

Precaution:

1 Please recharge the battery at least 4 hours before first time usage

2 In order to prevent cross-infection, it is forbidden to reuse the disposable sleeve

3 The top of the main unit can be turned 360 degrees to both left and right while it is forbidden to remove

4 During operation, the blue light should be aimed straightly at the omposite resin to ensure the effect of solidification

5 Avoid aiming the blue light at eyes directly

6 Please use the power adapter and lithium battery which is designed and supplied by our company. It may cause potential dangers to operator and patient by using the power adapter and lithium battery which is designed and supplied by other manufacturers

7 It is forbidden to use metal or other conductors to touch the main Init and the charging point of pedestal because it may burn the internal circuit or make the lithium battery short circuit

8 Please recharge the battery in cool and ventilated room

9 It is forbidden to self-taking apart the battery, in order not to result in short-circuit or leakage

10 It is forbidden to extrude, shake or rock the battery. The Li-ion battery is forbidden to be in short-circuit situation and it is forbidden to put the battery with metal or other conductors

11 To invoid electromagnetic interference, the device should be installed at the medical site which meet the requirement of EMC.

1.WARNING: If the curing light works for 40s continously, the temperature of the top of optical fiber may reach 56C

2.WARNING: Do not modify this equipment without authorization of the manufacturer.

3.WARNING: The adapter should be connected to the socket which is easy for operator to touch

4.WARNING: over-heat scorching: interval time should be no less than

Contraindication:

The heart disease patients, pregnant women and children should be cautious to use this equipment.

Daily maintenance:

1 This equipment does not include the self-maintainable spare parts

The maintenance of this equipment should be taken by the appointed professional or special repair shop

2 Users can change the disposable sleeve and lithium battery. Please use accessory which is designed and supplied by our company, contract with the local dealer or our company if you want to buy. It may cause potential dangers to curing light or other damages which is designed and supplied by other manufacturers

3 The accessory of the product should be cleaned by clean water or neutral sterilized liquid. Do not soak. Do not use highly volatile and diffluent solvent to clean this equipment, which can cause the signs on the control pa

4 Please clean the resin remained on the top of the main unit after using to avoid infecting the life-span or solidified effect

5 The device cannot be maintanenced during operation. And it is suggested to maintain it once a month. But sleeve is for one-time usage and no need for maintanance

 

510(K) Number: K192233

Regulation Number: 21 CFR 872.6070

 

Product Code: EBZ