1. Purpose & Environment 1.1 Purpose • This device is used for injection of medicine such as local anesthesia. • This device is classified as a internally powered medical device. Device name Model name Equipment Part Anesthesia injection system AN100 Type B 1.2 User &...
2. FCC Statement 2.1 FCC Statement Federal Communication Commission Interference Statement This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications.
3. Caution & Safety regulations Caution Be sure to read the user manual before using this product. Please use this product only for licensed dentists. When injecting the anesthetic solution into the patient using this product, adjust the injection amount according to the decision of the physician. Do not use on uneven floors, sloping areas or when there’s vibration.
3. Caution & Symbol 3.2 Symbol Part Symbol Explanation Instruction - Be sure to read this instruction manual before using it to prevent safety accidents and understand Manual essential performance before using It. (ISO 7010-M002) (show on Label) - Be careful not to touch the charging adapter with wet hands, as there is a risk of electric shock. Electricity (ISO 7010- W012) No activated...
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3. Caution & Symbol 3.2 Symbol Part Symbol Explanation Use no hand hooks - Do not use hooks when handling packing cargo. (show on label) Recycling - Indicate Recycling box location. (ISO 7001: 2007) (show on label) Atmospheric - Indicates the range of atmospheric pressure to which the medical device can be safely exposed. (ISO 15223-1:2012) (show on label) pressure limitation - Indicates the temperature limits to which the medical device can be safely exposed.
5. Function & Use 5.2 Function(LCD) ① ② ③ ④ ⑤ ⑥ Part Function Motor movement ① - Show forward( ), backward( ), stop( direction Current amount of ② - Show current amount of inject medicine(1 ~ 100%). inject medicine Amount of inject - Amount of inject medicine icon medicine...
5. Function & Use 5.3 Function(Sound) Part Order IMAGE Explanation Press Select button (SW3) for more than 2 seconds to enter setting mode. Setting Mode Setting Mode SOUND OFF SOUND ON Sound Set ON/OFF with Adjust Button (SW4) Press the SELECT button (SW3) for more than 2 seconds to exit the SOUND ON SOUND OFF setup mode.
5. Function & Use 5.4 Function(CRADLE) Part Name Explanation - When the main body is not in use, put it on a CRADLE and charge it. CRADLE - Store the Main body before and after use. DC power Port - Port to which the adapter jack can be connected. - Show charging status Charging light(GREEN) : Standby charging Charging light(BLUE) : Charging...
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5. Function & Use 5.5 Use(Basic function) Order Image Explanation Check the entire DENOPS component. (Main body, AMPOULE CASE, Adapter, CRADLE, User manual) Connect the ampoule to the AMPOULE CASE. 45˚ Rotate the AMPOULE CASE 45 degrees to connect the AMPOULE CASE and the main body.
5. Function & Use 5.5 Use(Basic function) Press SW1 (over than 2 seconds) to operate aspiration. Remove the needle cap and press SW1 to start injection. Press SW2 (over than 2 seconds) to initialize ampoule after completion of inject medication. 360˚...
5. Function & Use 5.6 Use(Change amount of inject medicine, Injection speed, Mode) Order Image Explanation Amount of inject medicine - Press SW3 to select the desired setting. change amount of inject medicine, injection speed, mode ※ Change User mode setting (Note P15) Injection speed Mode Change amount of inject medicine...
5. Function & Use 5.7 Use(Change User mode setting) Order Image Explanation - Press SW3 to select the desired mode. - In the Change Mode screen, press SW4 to select U1 to U5. - Press SW4 for more than 2 seconds to change the USER setting. - Press SW3 to select the desired mode change.
6. Disinfection, Sterilization and Storage 6.1 Disinfection(Main Body) • Before and after use, wipe with just a dry cloth or with a cloth using Enzyssept. • Please dilute the QUAT disinfectant and pour it into Dry Wipes. 6.2 Sterilization (AMPOULE CASE) •...
7. Trouble shooting and Warranty & Expected Service Life 7.1 Trouble shooting Num. Problem Cause Matter of management Drained battery Please charge the battery and use it again. The display does not turn on Etc. Contact the customer service center. Button does not operate Button failure Contact the customer service center.
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FACTORY : 6, Yuram-ro, Dong-gu, Daegu, Republic of Korea KOREA +82-2-869-6020 / USA +1-323-677-4363 ⓒ2021 DENTIS CO.,LTD. All Right Reserved. (Ver 1.0) Jun/30/2021 Specifications are subject to change without notice. Document No. : UEF-A1-11 Trademarks are the property of DENTIS CO., LTD. Or their respective owners.
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