Guilin Woodpecker Medical Instrument Endo 3 User manual

Contents

Preface-------------------------------------------------------------------- 1

1 Product introduction--------------------------------------------------- 1

2 Product components-------------------------------------------------- 1

3 Basic technical parameters------------------------------------------- 2

4 Installation and removal method ------------------------------------- 3

5 Operation--------------------------------------------------------------- 4

6 Charging instructions-------------------------------------------------- 5

7 Safety precautions----------------------------------------------------- 5

8 Product contraindications--------------------------------------------- 6

9 Cleaning, disinfection and sterilization ------------------------------- 7

10 Daily maintenance-------------------------------------------------- 13

11 Troubleshooting ---------------------------------------------------- 14

12 Storage and transportation---------------------------------------- 14

13 After-sales service-------------------------------------------------- 15

14 European authorized representative------------------------------ 15

15 Environment protection-------------------------------------------- 15

16 Symbol instruction ------------------------------------------------- 15

17 Electromagnetic compatibility------------------------------------- 16

18 Statement ---------------------------------------------------------- 21

Preface

Guilin Woodpecker Medical Instrument Co., Ltd is a professional

manufacturer researching, developing, and producing dental products.

Woodpecker owns a sound quality control system. Its main products

include Ultrasonic Scaler, Ultrasonic Endo Ultrasonic Endo Activate Device,

Curing light, Apex locator, Ultrasurgery, Automatic water supply system,

etc.

1 Product introduction

1.1 The features of Endo 3 Ultrasonic Endo Activate Device

a) Adopt microcomputer automatic control for the working process, which

makes the operation easier and efficient. There are one mode switching

button and a switch ring button. Press the mode switching button to adjust

the working state of the machine, and press the switch ring button to start

or shut down the machine.

b) This machine has three modes: shutdown mode, hot standby mode (in

this mode, power adjustment and time adjustment can be carried out) and

irrigation mode (working mode).

c) The machine has stable performance and adopts an automatic

frequency tracking system to automatically search for the best working

state.

d) The tips, Endo wrench and protective silicone cover can be autoclaved

under high temperature of 134°C and high pressure of 0.22Mpa.

e) The small vibration amplitude and high frequency of the tip enable the

efficient and safe irrigation.

1.2 Product model

Endo 3

1.3 Product principle and scope of application

1.3.1 Product principle

Endo 3 Ultrasonic Endo Activate Device mainly generates high-frequency

oscillating signals from the high-frequency oscillating circuit and acts on the

ultrasonic transducer. The ultrasonic vibration is generated by the inverse

piezoelectric effect, and the tip is stimulated to generate resonance. It can

deep into the root canal and utilizes various effects produced by ultrasonic

waves to drive the drug or liquid in the root canal, generating ultrasonic

flow and cavitation effects, and achieving the effect of irrigating stains and

debris.

1.3.2 Scope of application

Endo 3 Ultrasonic Endo Activate Device applies to root canal irrigation.

2 Product components

This product is composed of host, charging base, tips, Endo wrench, 5V

power adapter, disposable isolation sleeve, protective silicone cover.

Note: The isolation sleeve is for single use only, please do not reuse.

3 Basic technical parameters

3.1 Dimensions: 173.8mm×25.8mm×35.8mm

3.2 Net weight: 78g

3.3 Machine configuration list: See details in packing list

3.4 Classified by power supply: Powered by rechargeable batteries

3.5 Rechargeable lithium battery:

Battery mode: DLG 14500

Nominal voltage: 3.6V

Capacity: 750mAh

3.6 Power adapter:

Input: 100V-240V~ 50Hz/60Hz 0.4A MAX

Output: DC 5V/1A

Build-in fuse: T1AL 250V

3.7 Working tip parameters:

Output tip vibration frequency: 40kHz±10kHz

3.8 Software Version:V1.0.0

3.9 Environment parameters:

Environment temperature: +5°C ~+40°C

Relative humidity at 30% -75%

Atmospheric pressure:70kPa ~ 106kPa

3.10 Device safety classification:

3.10.1 Applied part: Tips

3.10.2 Type of Operation mode: Non continuous operating device.

Duty cycle:ON/OFF:Max 1min/Min 2min

3.10.3 Type of protection against electric shock: Class II equipment with

internal power supply

3.10.4 The contact duration of applied part:No more than 1 minute.

3.10.5 The temperature of the surface of applied part may reach 48℃.

3.10.6 Degree of protection against electric shock: BF type applied part

3.10.7 Degree of protection against harmful ingress of water: Ordinary

equipment (IPX0)

3.10.8 Degree of safety application in the presence of a flammable

anesthetic mixture with air, oxygen, or nitrous oxide: Equipment cannot be

used in the presence of a flammable anesthetic mixture with air, oxygen, or

nitrous oxide.

4 Installation and removal method

Before use: Install the disposable isolation sleeve first, then install the

protective silicone cover, and finally install the tip.

After use: First remove the tip, then remove the protective silicone cover,

and finally remove the disposable isolation sleeve.

4.1 Installation and removal of disposable isolation sleeve

4.1.1 Installation

Before each use of the host and after the host is cleaned and disinfected,

put on a disposable isolation sleeve. Take the isolation sleeve out of the

isolation sleeve box, then insert the isolation sleeve into the host from the

thin end of the host, and install the isolation sleeve until there is no obvious

wrinkle.

4.1.2 Removing

After each use, slowly pull the isolation sleeve from the thin end of the

host.

Warning: Isolation sleeves are not reusable.

4.2 Installation and removal of protective silicone cover

4.2.1 Installation

Before each use of the host, put on a sterilized protective silicone cover.

Align the protective silicone cover with the head of the host and put it on

gently.

4.2.2 Removal

After each use, slowly remove the protective silicone cover from the host.

4.3 Installation and removal of the tip

Screw the tip with an Endo wrench in clockwise direction and press the

button to use the machine. (Rotate the tip counterclockwise to remove it.)

The installation and removal method of the tip is shown in the figure below:

Note: The installation or removal of the tip shall be carried out under the

shutdown mode of the host.

Tighten clockwise to install the tip Unscrew counterclockwise to remove the tip

4.4 For battery charging, plug the host into the charging base and press

tightly to make the host and base tightly match. While not charging, please

keep the charging base power off.

5 Operation

Buttons and screen display:

5.1 Under the shutdown mode of the host, press the mode switching

button lightly and the host would enter the hot standby mode. Under

the hot standby mode, lightly press the mode switching button to select

the power level of the host. After selecting the power, press the mode

switching button and the ring switch button at the same time, the host will

enter the time adjustment state (at this time, the middle character will jump

constantly). And then, lightly press the mode switching button to select the

duration time of the irrigation mode. There are four kinds of working time of

this machine: 10, 15, 20 and --, which means 10s, 15s, 20s and 10min

respectively.After selection, press the mode switching button and ring

switch button at the same time again, the host will exit the time adjustment

state.

5.2 When using, first inject the liquid medicine into the root canal, next set

the power level and the irrigation time of the host, then put the tip into the

appropriate position of the root canal, lightly press the ring switch button

of the host, and the host will automatically adjust to the best working

condition for work. After the irrigation, press the ring switch button to stop

irrigation (or the host will stop irrigation after the irrigation time is over). After

replacing the liquid medicine, lightly press the ring switch button again to

re-enter the irrigation mode. In general, a complete root canal irrigation

requires replacing the liquid medicine 7-8 times.

5.3 After the treatment, long press the mode switching button and the host

would enter the shutdown mode.

5.4 The tip and Endo wrench can be autoclaved under high temperature

of 134°C and high pressure of 0.22MPa.

5.5 Low voltage indication: If the screen shows that there is only 1 grid

voltage left, it means that the battery is about to be exhausted and needs

to be charged as soon as possible.

6 Charging instructions

6.1 Use the charging base corresponding to this machine to charge:

Connect the power adapter to the charging base and turn on the power,

and then put the main unit of Ultrasonic Endo Activator on the charging

base. When charging, the battery indicator on the screen will continue

to flip. When the indicator stops at 4 grids position and stops flipping, it

means charging is finished. Under normal circumstances, it takes 4 hours

to charge. When fully charged, the machine can continue to work for 1

hours.

6.2 The battery used in this product has no memory and can be charged

at any time.

6.3 Before first use of this machine, please charge for at least 4 hours.

7 Safety precautions

7.1 A tip engraved with the "WOODPECKER" logo cannot be used on a

host engraved with the "DTE" logo and vice versa.

7.2 Keep the machine clean before and after operation.

7.3 Operators should be equipped with adequate protections such as

goggles, masks, etc. to prevent cross-infection while operating.

7.4 The use of the product must meet the requirements of the relevant

operation normalization and relevant regulations of medical department, and

the use is limited to the trained doctors or technicians.

7.5 The tip,protective silicone cover and Endo wrench must be sterilized

before each treatment.

7.6 Please install or remove the tip under shutdown mode.

7.7 The tip must be tightly screwed.

7.8 During operation, it is necessary to drip water for cooling. At the same

time, the water dripping instrument needs to be isolated from the earth.

7.9 The damage or wear of working tip will result in vibration intensity

decrease. The operator should replace the work tip according to the clinical

situation.

7.10 Don’t twist or polish work tip.

7.11 Don’t strike or scratch the host.

7.12 When charging with the adapter, keep the contact with the adapter

housing for less than 1 min.

7.13 Please long press the mode switching button to make the host enter

the shutdown mode after each treatment.

7.14 Replacement of lithium batteries by inadequately trained personnel

and incorrect replacement of lithium batteries could result in a HAZARD,so

please contact local distributors to replace the battery if necessary.

7.15 The adapter plug can be used to disconnect from the network

power supply.Don't position the device to make it difficult to operate the

disconnection device.

7.16 Woodpecker is specialized in producing medical instrument. We are

only responsible for the safety on the following conditions:

a) The maintenance, repair, and modification are made by the manufacturer

or the authorized dealers.

b) The charged components are original of “DTE or Woodpecker” and

operated according to instruction manual.

7.17 The internal thread of Ultrasonic Endo activating file produced by

some other manufacturers maybe coarse, rusty, collapse, or use other

standard thread. It will be easy to be broken or cause slide teeth while

matching the external thread of host, resulting in damage beyond repair of

the Ultrasonic Endo activating file. Please use “DTE or Woodpecker” brand

work tips.

7.18 HAZARDS that can result from unauthorized modification of the

device.

8 Product contraindications

8.1 The hemophilia patient is forbidden to use this equipment.

8.2 The patients with heart pacemaker are forbidden to use this equipment.

8.3 The patients with heart pacemaker are forbidden to use this

equipment.

8.4 Heart disease patients, pregnant women and children should be

cautious to use the equipment.

9 Cleaning, disinfection and sterilization

This product is provided non-sterile, please clean, disinfect and sterilize

tip, Endo wrench and protective silicon cover before use.The cleaning,

disinfection and sterilization of tip, Endo wrench and protective silicon

cover are as follow.

Unless otherwise stated, they will be hereinafter referred to as “products”.

Warnings

The use of strong detergent and disinfectant (alkaline pH>9 or acid pH<5)

will reduce the life span of products. And in such cases, the manufacturer

takes no responsibility.

The products may not be exposed to temperature above 138°C.

Processing limit

The products have been designed for a large number of sterilization cycles.

The materials used in manufacture were selected accordingly. However

with every renewed preparation for use, thermal and chemical stresses will

result in ageing of the products. The maximum number of sterilizations for

tips is 300 times. For wrench, it is 1000 times. And for protective silicon

cover, it is 300 times.

9.1 Initial processing

9.1.1 Processing principles

It is only possible to carry out effective sterilization after the completion

of effective cleaning and disinfection. Please ensure that, as part of

your responsibility for the sterility of products during use, only sufficiently

validated equipment and product-specific procedures are used for

cleaning/disinfection and sterilization, and that the validated parameters are

adhered to during every cycle.

Please also observe the applicable legal requirements in your country as

well as the hygiene regulations of the hospital or clinic, especially with

regard to the additional requirements for the inactivation of prions.

9.1.2 Post-operative treatment

The post-operative treatment must be carried out immediately, no later than

30 minutes after the completion of the operation. The steps are as follows:

1. Wet the soft cloth completely with distilled water or deionized water,

and then wipe all the surfaces of the tip and host until the surface of the

component is not stained;

2. Dry the product with a clean, soft cloth and place it in a clean tray.

Notes:

a) The water used here must be pure water, distilled water or deionized

water.

9.2 Preparation before cleaning

Steps:

Tools: Endo wrench, tray, soft brush, clean and dry soft cloth

1. Remove the tip from host with Endo wrench provided by Guilin

Woodpecker Medical Instrument Co., Ltd, and then put the tip and wrench

into a clean tray.

2. Remove the protective silicon cover from host and put it into the tray.

3. Remove the disposable isolation sleeve from host.

Disassembling steps

9.3 Cleaning

The cleaning should be performed no later than 24 hours after the

operation.

The cleaning can be divided into automated cleaning and manual cleaning.

Automated cleaning is preferred if conditions permit.

9.3.1 Automated cleaning

• The cleaner is proved to be valid by CE certification in accordance with

EN ISO 15883.

• There should be a flushing connector connected to the inner cavity of the

product.

• The cleaning procedure is suitable for the product, and the irrigating

period is sufficient.

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