DENTIST AN100-C Anesthesia Injection System User Manual

DENOPS User Manual

Purpose & Environment

1.1 Purpose

• This device is used for the injection of medicine such as local anesthesia.
• This device is classified as an internally powered medical device.

Device name	Model name	Equipment Part
Anesthesia injection system	AN100	Type B

1.2 User & Patient

• Only a doctor or specialist should use this device.
• A doctor or specialist may permit a nurse to manage the device but they should not operate it. For example, they may charge, assemble and hold the product before using, and sterilize and store it after use.
• There is no limit on the gender and age of the patient, but it can be applied differently depending on the doctor’s prescription.

1.3 Environment(Transport and Storage, Use)

• Temperature : 0 – 40 ℃
• Relative humidity : 30 – 90 %RH
• Humidity : 0 – 2,000 m (106 – 80 Kpa)

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. However, there is no guarantee that interference will not occur in a particular
installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one of the following measures:

• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and receiver.
• Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
• Consult the dealer or an experienced radio/TV technician for help.

FCC Caution: Any changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate this equipment.
This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.

2.2 FCC Radiation Exposure Statement:
This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment.
This equipment should be installed and operated with a minimum distance of 15cm between the radiator & your body.
This device and its antenna(s) must not be co-located or operated in conjunction with any other antenna or transmitter.

 Caution & Safety regulations

3.1 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.
• Do not use in water or humid areas.
• Do not touch the main body and power plug with wet hands.
• Be careful not to move or get an external shock when operating the machine.
• If the product smells of smoke or burning, please contact the place of purchase.
• This device complies with electromagnetic specifications. However, this equipment can cause improper operation due to loss of performance or degradation due to external electromagnetic disturbances.
• Please check if all the components are present after opening this product.
• Please do not use any adapter other than the one provided by the manufacturer.
• Unplug the adapter connected to the cradle in case of abnormal operation or problems with the product.
• If the wire is damaged, please stop using it and contact the place of purchase to replace it.
• Never use this product for anything other than its intended use.
• Do not disassemble or modify unless by a technician from the place of purchase. No warranty shall be granted for arbitrary disassembly and modification.
• Please do not use the used ampoule again.
• Store the product in a CRADLE when not in use.
• This device has obtained electromagnetic compatibility KC, CE, and FCC certification.
• In case of malfunction or damage, please contact the place of purchase
• Please dispose of the product in accordance with the laws of your country.
• When replacing the battery, contact the manufacturer of the product.
• Electric shock hazard, do not saturate the Pump with liquids. Protect the Pump from exposure to condensed humidity, moisture, and liquid.
• When used in the vicinity of an electric scalpel (a medical scalpel is an incision and resurfacing device using high-frequency current), check the following before use – The distance from the pump to the electric scalpel (scalpel, scalpel, and return electrode) and the scalpel should be kept at least 25cm. – The electric scalpel and this pump should operate with the power from a separate system and connect them safely.

Caution & Symbol

3.2 Symbol

Part	Symbol	Explanation
Instruction Manual		– Be sure to read this instruction manual before using it to prevent safety accidents and understand essential performance before using It. (ISO 7010-M002) (show on Label)
Electricity		– Be careful not to touch the charging adapter with wet hands, as there is a risk of electric shock. (ISO 7010- W012)
No activated Mobile phone		– Do not use wireless equipment such as mobile phones within 30 cm during the procedure as malfunctions may occur due to external electromagnetic forces. (ISO 7010-P013)
Sharp		– Be careful not to get stung. (ISO 7010-W022)
Warning		– Be careful not to drop the body on the floor during use. (ISO 7010-W001)
Wash your hand		– Make sure to wash your hands before and after use. (ISO 7010-M011)
This side up		– Indicates the correct direction of the package. (show on the label)
Keep dry		– Indicates a medical device that needs to be protected from moisture. (ISO 15223-1: 2012) (show on the label).
Fragile		– The contents of the packaging are fragile, so be careful and handle them. (ISO 15223-1: 2012) (show on the label).
Stand-by		– To identify the switch or switch position by means of which part of the equipment is switched on in order to bring it into the standby condition. (IEC 60417-5009)
Serial number		– Indicates the manufacturer’s serial number so that a specific medical device can be identified. (ISO 15223-1)(show on the label)
Date of manufacture		– Indicates the date when the medical device was manufactured. (ISO 15223-1)(show on the label)

Part	Symbol	Explanation
Use no hand hooks		– Do not use hooks when handling packing cargo. (show on the label)
Recycling		– Indicate the Recycling box location. (ISO 7001: 2007) (show on the label)
Atmospheric pressure limitation		– Indicates the range of atmospheric pressure to which the medical device can be safely exposed. (ISO 15223-1:2012) (show on the label)
Temperature limit		– Indicates the temperature limits to which the medical device can be safely exposed. (ISO 15223-1:2012)(show on the label)
Humidity limitation		– Indicates the range of humidity to which the medical device can safely expose. (ISO 15223-1:2012) (show on the label)
Sterilization		– After use, make sure to sterilize the AMPOULE CASE with steam in the autoclave and store it in a sterilization bag for the next use. (ISO 7000-2868)
Discard		– Do not dispose of this device with unsorted waste. Please separate recyclable parts and throw them away separately Classify recyclable parts and throw them away. (Directive 2002/96/EC) (show on the label)
Type B Equipment Part		– This medical device corresponds to the type B Equipment part. (IEC 60417-5840) (show on the label)
Class 2		– This device is a 2-class medical device. (IEC 60417-5172) (show on the label)
Manufacturer		– Indicates the medical device manufacturer (Directives 90/385/EEC, 93/42/EEC, and 98/79/EC)(show on the label)
EU representative		– Indicates the authorized representative in the European Community.

Configuration & Specification

4.1 Configuration

AMPOULE CASE	Main Body	CRADLE

Adapter	User Manual

4.2 Specification

List	Category	Unit	Specification	Etc.
Main body (+ AMPOULE CASE)	Weight	g	85
	Amount of inject medicine	ml	Adjust 5 Steps (Check the steps with the LCD) 1/16 : 0.11m1, 1/8 : 0.22m1, 1/4 : 0.45m1, 1/2 : 0.90m1, Full : 1.8m1
	Injection time	s	Manual – lstep : 320s, 2step : 160s, 3step : 30s Auto – lstep : 320s, 2step : 170s, 3step : 48s	1.8m1
	Mode	–	AUTO, MANUAL, USER
	Battery	V	4.	Lithium Polymer
		mAh	550
	Charging time	h	6
	Size	mm	202.5 X 24.7 X 28
CRADLE	Weight	g	140
	Size	mm	176 X41.4 X75.3
Adapter	Rated input	V	AC 100 — 240
		Hz	50/60
	Rated output	V	DC 5
		A	2.0
	Weight	g	104
Dental needle (Disposable, Separately sold)	Size	mm	27G/16, 25, 30 30G/ 12, 16, 25 31G/ 12

Function & Use

5.1 Function(Main body)

Part	Name	Function
LCD	LCD	– Show main body status
SW1	Operation button	– Injection of medication / Stop – Aspiration (Over 2 seconds)
SW2	Reset button	– Remove bubble – Initialization(Over 2 seconds)
SW3	Select button	– Move menu: Amount of inject medication, Injection speed, Select Injection mode – Sound Setting(Over 2 seconds)
SW4	Adjust button	– Step Setting – Save User mode(Over 2 seconds)
SW5	Power button	– Power On/Off(Over 2 seconds)
SW3+SW4	Connect hook	– Hook the motor pin to the back of the ampule (Setting before using the aspiration)

5.2 Function(LCD)

No.	Part	Function
1	Motor movement direction	– Show forward-backward) stop
2	Current amount of inject medicine	– Show the current amount of injected medicine(1 — 100%).
3	Amount of injected medicine	– Amount of injected medicine icon
	Adjust amount of inject medicine	– Show the amount of injected medicine such as FULL, 1/2, 1/4. 1/8, 1/16.
4	Injection speed	– Injection speed icon.
	Adjust Injection speed	– Show injection speed(1 — 3 Steps).
5	Battery	– Show current battery status.
6	Mode	– Auto(A) : Low-speed to high-speed injection.
		– Manual(M) : Inject at a constant speed.
		– User(U1—U5) : Save user-specified amount of injected medicine and injection speed and use.

5.3 Function(Sound)

Part	Order	IMAGE		Explanation
Sound	1			Press the Select button (SW3) for more than 2 seconds to enter setting mode.
	2			Set ON/OFF with Adjust Button (SW4)
	3	SOUND ON	SOUND OFF	Press the SELECT button (SW3) for more than 2 seconds to exit the setup mode.
Language	1			Press the Select button (SW3) for more than 2 seconds to enter setting mode.
	2			Press the SELECT button (SW3) to change to LANGUAGE SELECT mode.
	3			Press the adjustment button (SW4) to select the language (KOR, ENG, CHN).
	4	Language(KOR, ENG, CHN)		Press the Select button (SW3) for more than 2 seconds to enter setting mode.

Voice Guidance
1	POWER ON	Start pain-free anesthesia.	5	Low Battery	Please charge the battery.
2	POWER OFF	Treatment complete.	6	Reay to Aspiration	Ready for Aspiration.
3	AMPOULE RESET	Reset the ampoule position.	7	Remove Bubble	Remove air bubbles.
4	SOUND ON	Activate voice assistant.	8	SOUND OFF	Turn off voice assistant.

5.4 Function(CRADLE)

Part	Name	Explanation
A	CRADLE	– When the main body is not in use, put it on a CRADLE and charge it. – Store the Main body before and after use.
B	DC Power Port	– Port to which the adapter jack can be connected.
C	LED	– Show charging status Charging light(GREEN) : Standby charging Charging light(BLUE) : Charging
D	Adapter	– Connect Plug to Outlet after connecting charging DC JACK to DC power port

Only use the supplied charging adapter for charging.

5.5 Use(Basic function)

Order 1	Image		Explanation
		•Check the entire DENOPS component. (Main body, AMPOULE CASE, Adapter, CRADLE, User manual)
2		•	Connect the ampoule to the AMPOULE CASE.
3		•	Rotate the AMPOULE CASE 45 degrees to connect the AMPOULE CASE and the main body.
4		•	Press SW5 (over 2 seconds) to turn on the power and display.
5		•	After checking the amount of injected medication (100%) on the LCD and the ampoule reset, press 5W3 and 5W4 at the same time to connect the hook. )K Use only when using aspiration (optional)
6 7	–	•	Set amount of injecting medicine, injection speed, mode X Note page 14
		•	Turn the needle 360 degrees to connect it to the main body. X Before using DENOPS, keep the needle covered with a cap.
8		•	Press SW2 to remove the air bubble.(remove bubble after removing the cap)

5.5 Use(Basic function)

9		Press SW1 (over than 2 seconds) to operate aspiration.
10		Remove the needle cap and press SW1 to start the injection.
11		Press SW2 (over 2 seconds) to initialize the ampoule after the completion of injecting the medication.
12		Turn the needle 360 degrees in the reverse direction to separate the needle.
13		Disconnect the AMPULLE CASE by turning the AMPOULE CASE to 45 degrees on the main body.
14		Separate AMPOULE CASE and ampoule.
15		Attach the main body to the CRADLE and charge and store it.

5.6 Use(Change amount of inject medicine, Injection speed, Mode)

`Order	Image	Explanation
1		– Press SW3 to select the desired setting. change amount of inject medicine, injection speed, mode ※ Change the User mode setting (Note P15)
2		– Press SW4 to select the desired step. Amount of inject medicine: 1/16, 1/8, 1/4, 1/2, FULL Injection speed: STEP 1, 2, 3 Mode: AUTO, MANUAL, USER 1 ~ 5

5.7 Use(Change User mode setting)

`Order	Image	Explanation
1		– Press SW3 to select the desired mode.
2		– In the Change Mode screen, press SW4 to select U1 to U5.
3		– Press SW4 for more than 2 seconds to change the USER setting.
4		– Press SW3 to select the desired mode change. Amount of inject medicine, Injection speed – Press SW4 to select the desired step. Amount of injected medicine: 1/16, 1/8, 1/4, 1/2, FULL Injection speed: STEP 1, 2, 3
5		– Save the User mode by pressing SW4(over 2 seconds) after changing the amount of injected medicine and injection speed.
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 QAT disinfectant and pour it into Dry Wipes.

6.2 Sterilization (AMPOULE CASE)

• The use of the following substances is not permitted.
  – High concentrations of organic acids and inorganic acids, hydrocarbons chlorinated
• Sterilization condition(Please refer to the sterilization method for each country.)

`Sterilization condition
Operating Condition • Temperature: 132 ℃(270 ℉) • Pressure: 150 kPa (1.6 kg/㎠) • pre-vacuum: 8 min(Wrapped) • Dry: 30 min

6.3 Storage

• Place DENOPS on CRADLE to charge after use.
• Please keep it away from places where there is humidity or water.
• Do not store near firearms.
• Store the product at room temperature and out of direct light.

Troubleshooting and Warranty & Expected Service Life

7.1 Troubleshooting

Num.	Problem	Cause	Matter of management
1	The display does not turn on	Drained battery	Please charge the battery and use it again.
		Etc.	Contact the customer service center.
2	The button does not operate	Button failure	Contact the customer service center.
3 4	Not Charging	CRADLE breakdown	Contact the customer service center.
		faulty adapter	Contact the customer service center.
	The device is running hot	–	Contact the customer service center.
5	Damage to the device and other problems	–	Contact the customer service center.

7.2 Warranty & Expected Service Life

• The warranty period of this product is 1 year.
• The expected service life of this product is 3 years.
•  The expected service life of a lithium-polymer charging battery is 300 charging cycles, 4.1V full charge, and 3.1V full discharge.
• Free maintenance will be provided during the warranty period if a user has unexpected problems while following instructions correctly.
• If there is a problem due to user carelessness or product modification or disassembly, you need to pay for the repair

DENTIST Co., LTD.
HEADQUARTER: 99, SeongSeoseo-ro, Dalseo-gu, Daegu, Republic of Korea
FACTORY: 6, Yuram-to, Dong-gu, Daegu, Republic of Korea
KOREA +82-2-869-6020 / USA +1-323-677-4363
ⓒ2021 DENTIST CO., LTD. All Right Reserved.
Specifications are subject to change without notice.
Trademarks are the property of DENTIST CO., LTD., Or their respective owners.
(Ver 1.0) Jun/30/2021
Document No. : UEF-A1-11

References

• Redirect Notice