VRN DA-20 Ultrasonic Scaler User Manual

June 20, 2024
VRN

VRN DA-20 Ultrasonic Scaler User Manual

Copyright & Declaration

Copyright URIT Medical Electronic Co., Ltd. All rights reserved.

This document is an English translation of the original Chinese version.

Congratulations on your purchase of DA-20 Ultrasonic Scalier from URIT Medical Electronic Co., Ltd. .It will bring you a new experience and convenience.

The manual is compiled in accordance with the relevant laws and regulations of China and the specific conditions of the DA-20 manufactured by URIT Medical Electronic Co., Ltd.

The manual includes the latest information as of the time of printing. URIT Medical Electronic Co., Ltd. is solely responsible for the revision and explanation of the simplified Chinese version of the manual, and reserves the right to change the relevant content after the manual is printed without prior notice.The pictures involved in this manual are schematic diagrams and are for reference only. If the pictures do not match the actual product, the actual product shall prevail.

All materials in this manual are protected by copyright law. Without the prior written consent of URIT Medical

Electronic Co., Ltd., any form of reproduction, photocopying, or translation of any content in the manual is not allowed to be translated into other languages.

The operator must strictly follow this manual to operate. Otherwise, URIT Medical Electronic Co., Ltd. shall not be responsible for any errors and equipment failures caused by illegal operations.

NOTICE: URIT Medical Electronic Co., Ltd. does not promise that the device will be used for a certain special purpose and make any implied guarantee for its marketability and applicability.
If you need after-sales service support, please contact Linguine Overrun Medical Technology Co., Ltd. or an author indigent.

Introduction

Overview
DA-20 adopts piezoelectric ultrasonic technology, which uses high-frequency and high-energy vibrations generated by ultrasonic waves to clean the surface of the teeth, break up calculus and stains in the periodontal pockets by tips, and then the rubble and plaque are washed down by the water spray produced by the device. It is designed for vaginal, submarginal cleaning and root canal washing and has the function of automatic water supply. It has following characteristics:

  • The irrigation system inside the product is made of anti-bacterial materials. The liquids used in clinics, such as hydrogen peroxide, chlorine, sodium hypocrite, etc., can be applied in the mode of automatic water supply system, which can significantly improve the performance of teeth cleaning and root canal washing.
  • The hand piece can be sterilised at 135℃ temperature and 0.22 MPa pressure.
  • Automatically search for the best working condition, the performance of device is more stable.
  • The device has a built-in computer micro processing chip, which can intelligently control the working power and make treatment more comfortable.
  • The wireless foot switch is used to remotely control the unit, which is more convenient to operate. At the sometime, wired foot switches can also be selected according to user needs.
  • High-brightness LED, which can improve the efficiency of clinical operation, and it can also use ordinary plug-in hand piece that has high compatibility.
  • The product service life is 10 years.

Equipment description
The product is mainly composed of function control circuit, power supply circuit, irrigation system, tip, hand piece, and foot switch.

Intended use
The product is intended use for removing tartar, plaque on the surface of teeth and in periodontal pockets, cleaning and washing root canals.

Contraindications

  • Patients with haemophilia is forbidden.
  • Patients with heart pacemaker is forbidden.
  • Doctors with heart pacemaker is forbidden.
  • Use with caution in patients with heart disease, pregnant women and young children.

Technical parameters

  • Input Voltage :220 V±22 V~,50/60 Hz

  • Input Power :35 VA

  • Batteries of wireless foot switch :AA Batteries×2

  • Receiving sensitivity : -114 dB, receive frequency:2.4 G-2.5 G

  • Tip amplitude: minimum,1 μm, deviation -50% maximum, 100 μm, deviation +50%

  • Half deflection force: minimum, 0.1 N, deviation -50% maximum, 5 N,deviation +50%

  • Vibration frequency of tip :18 kHz~45 kHz
    Note: The vibration frequencies of different types tips are different, but they are all distributed within the described range.

  • Output Voltage of tip :3 W~20 W

  • Fuse: T1AH250V

  • Weight: 1.8 kg

  • Operation modes :continuous running

  • Protection against electric shock rating :Class Ⅱ equipment

  • Protection against electric shock degree :B-type application part

  • Ingress protection rating : Ordinary equipment (IPX0), Wired foot switch is waterproof equipment( IPX1) ,Wireless foot switch is waterproof equipment(IPX4)

  • Degree of safety application in the presence of a flammable ans the tic mixture with air, oxygen, or nitro us oxide: Non-AP,APG type equipment

  • Wireless foot switch:
    Emission frequency : 2.412 GHz-2.462 GHz
    Modulation type : GFSK
    Effective radiated power: 12 dbm

Operation environment

a)Ambient temperature: 5 ℃~ 40 ℃
b)Relative humidity: ≤80%
c)Atmospheric pressure: 70 kPa~106 kPa
d)Applicable range of power supply voltage :220 V±22 V~

Side effects, adverse events and measures
According to the results of many years of clinical treatment with similar equipment, there are no serious side effects except that the enamel of the treatment site may leave a few scratches that can be recovered.
If any unexpected action occurs during the use of this device, please immediately power off it to stop the device tonsure safety.When using the device, pay attention that the tip needs enough water to dissipate heat, otherwise Rayburn the patients. If burns occur, please stop using the device immediately and perform corresponding diagnosis and treatment according to the burns.

Installation

Front/Back view

Figure 2.1:

Solution container: Storage solution for scaling.
Slider for changing power scale and indicator light:  it used for changing power scale and displays the power scale of the current working state.
Slider for changing liquid flow rate and indicator light: it used for changing liquid flow rate at the tip and displays the flow rate of the current working state.
Tip: used in conjunction with ultrasonic scale for cleaning and reshaping the surface of teeth, root canals and other parts
Hand piece: used in conjunction with scale with water spray function
Hand piece cord: used to connect hairpiece and unit
Undo mode key, indicator light :switching the end mode, the light is on to indicate that the ultrasonic scalier is innuendo state.
Period mode key, indicator light :switching the period mode, the light is on to indicate that the ultrasonic scale is interior state.
Scaling mode key, indicator light :switching the scaling mode, the light is on to indicate that the ultrasonic scale is in Scaling state.
Figure 2.2:

Power switch : switching the power state
Power outlet: power input
Fuse holder : place the fuse

Connection of the accessories
Socket of wired foot switch is at the bottom of the device, it will be inserted into the forward or backward of the wire groove firstly according to the user’s needs.

**Solution container installation

Hand piece installation

Tip installation

**

Matching code for wireless foot switch

  1. Press and hold the three keys “G”, “P” and “E” at the same time until the indicator light of liquid slider starts to flash slowly under the device is power on.
  2. Keep foot switch pressed and insert two AA batteries (operate when indicator light of liquid slider starts to flash slowly at the same time) ,and then foot switch will enter matching mode and it should keep pressed state for 3 seconds after it is power on.
  3. Loosen foot switch and restart, and the device can be controlled by wireless foot switch.
  4. Press and hold the three keys “G”, “P” and “E” at the same time when these three modes are at 10 scales, and the device will cancel all match.
  5. Press and hold the three keys “G”, “P” and “E” at the same time when the liquid flow rate is 10 scales, the device will enter the calibration mode of liquid flow rate. Don’t enter this mode under normal circumstances. If necessary, please contact the dealer or contact the manufacturer.
    Note :Tear off the membrane behind the sticker and stick it on the bottom of foot switch for water proofing.

Press “1” to start the device.

Operating instruction

Major components of hand piece
Cone head: it can be unscrewed, users can take out the bonehead regularly and clean the main pole with alcohol.
Light guide: it can be cleaned with alcohol.
Hand piece: Pit is the important parts of the device, which can be at high temperature and high pressure environment.
Hand piece cord: it is used for connecting the hand piece and irrigation system and circuit of the unit .

NOTICE: Please keep the hand piece and socket dry.

Torque wrench

  1. The design of torque wrench adopts a special structure, which can ensure the user can effectively load and unload the tip and protect the user’s hand during use, and it can avoid be scratched by the tip when load and unload the tip( See Figure 2.6).
  2. Put the tip into the wrench and hold the hand piece tightly, rotate the tip in a clockwise direction till the tip doesn’t turnaround anymore, and then it is installed.
  3. Unload the tip : Hold the hand piece and rotate the tip in a counter-clockwise direction by wrench to remove it.
  4. Once after using, please put the wrench into sterilisation cabinet to sterilise.
  5. After sterilisation, due to the high surface temperature of the torque wrench, the wrench needs to be cooled before it can be used again to avoid burns.
  6. When the torque wrench is not in use, place it in a ventilated and dry place and keep it clean.

Scaling function for vagina and submarginal

  1. Open the package and check whether the accessories of the product are complete according to the packing list.Take out the device from the box and place it on a stable surface facing the operator.
  2. Set the slider for changing liquid flow rate to the max scale.
  3. Insert the battery into the wireless foot switch or insert the plug of the wired foot switch into the foot switch-socket (See Figure 2.3 and Figure 2.7).
  1. Open the solution container cap, put a proper amount of pure water into container, close the cap, and install the container to the installation position of container on the device (Figure 2.4).
  1. Fasten the tip to the hand piece with torque wrench (See Figure 2.6 ), and then correctly connect the handwritten the hand piece cord socket. Before installing the hand piece, dry the connection end of the mantelpiece and the socket thoroughly (Figure 2.5).
  2. Power off the device, then connect the output of the power cord to the device, and then connect the input of the power cord to the electric supply (See Figure 2.2).
  3. Power on the device, and the“G”indicator light and the first 3 power indicator lights will light up at this time.
  4. The operator selects the “G” and “P” modes according to the series of the tips, and the power of the tip is shown in the attached table.
  5. The frequency is relatively fast when the product is working normally, ensure that the device has normal water output, only light touch and reciprocating movement at a certain speed can be used to eliminate dental calculus,and there is no obvious feeling of heating at the tip; Excessive local force or staying for too long when cleaning teeth.
  6. Vibration intensity: adjust the vibration intensity according to your needs. Generally, user can adjust it to medium vibration intensity. User can also adjust the vibration intensity at any time during the clinical process according to the patient’s sensitivity and the hardness of the calculus.
  7. Liquid flow rate: step on the foot switch, the tip will vibrate, slide the liquid slider to make the liquid into semiautomatic state to cool the tip and clean the teeth.
  8. Generally use the pen position to hold the hand piece.
  9. During scaling, do not make the tip be in vertical contact with the teeth, and do not apply heavy pressure to avoid damage to the teeth and tip.
  10. After completing scaling, keep working for 30 seconds under the water supply to clean the hand piece and tip.
  11. Remove the tip and then pull out the hand piece for sterilisation.

NOTICE:

  1. Please do not pull out the hand piece when stepping on the foot switch and the tip vibrates.
  2. If do not use the wireless foot switch for a long time, please remove the battery.
  3. Please do not move or turn over the device when it is working.

Endo function

  1. Fix the holder of endo file to the hand piece with endo wrench ( See Figure 2.6 ).
  2. Unscrew the nut of the holder .
  3. Insert the endo file into the hole in front of the holder.
  4. Tighten the nut of the endo file with end wrench.
  5. Press “E”, the “E” indicator lights up.
  6. When the Endo function is selected, slowly extend the endo file into the patient’s root canal, step on the foot switch and start the root canal washing. Adjust the power of root canal washing as needed.

NOTICE:

  1. Tighten the endo tip.
  2. Tighten the nut of the holder.
  3. Do not apply heavy pressure when root canal washing.
  4. Do not step on the foot switch when the endo file is not placed in the root canal.
  5. It is recommended that the power adjustment start from the 1st scale and slowly increase to the 3rd scale when using the Endo function.
  6. Please do not move or turn over the device when it is working.

Wireless foot switch

Operating

  1. Put 2 AA batteries into the wireless foot switch in the direction indicated by the positive and negative poles,install the battery cover and glue the waterproof rubber pad, and tighten the cover screws.
  2. Place the wireless foot switch flat on the ground.
  3. After matching with ultrasonic scale, power on the device and then user can use the wireless foot switch to control the device.
  4. Within 5 meters of the ultrasonic scale, the vibration of the device can be controlled by the wireless foot switch at any position. Please be careful not to have large obstacles between the foot switch and the device, so as not to affect the wireless transmission.

Automatic water supply

Operating:

  1. Pull out the container installed on the device vertically upwards.
  2. Open the cap of container, add enough pure water, and then close the cap tightly.
  3. Clean bottleneck and socket connection of container.
  4. Insert the container vertically into the container interface of automatic water supply on the device.

NOTICE:

  1. Make sure that the air vent and water outlet are not blocked.
  2. Check if the gasket in the cap is fine. If the gasket is deformed or falls off, please replace and installit in time.
  3. Please clean the connection of the container before each use.
  4. Please add liquid in time to keep the liquid path unblocked when the liquid in the container is lower than the lower limit.

Precautions

  1. Keep the device clean and dry before or after use.
  2. Prohibit suspended or inverted device.
  3. Before each use, please let the device work for 30 seconds under the condition of water to remove the residual water in the pipeline.
  4. The operator should be equipped with adequate protection (such as goggles, mask, etc.) to prevent cross-infection.
  5. Using the product must comply with the requirements of the relevant operating specifications and relevant law sand regulations of the medical department, and it is limited to trained doctors or technicians.
  6. Before each use, please sterilise the tip, wrench and other accessories.
  7. Don’t tighten or loosen the tips when the hand piece is activated.
  8. Tighten the tips.
  9. When the tip is damaged or worn, the vibration intensity will decrease. The operator should replace the tip with new one according to the clinical situation.
  10. Don’t bend or sharpen the tips.
  11. Don’t use unclean water, and do not use normal saline instead of pure water sources.
  12. Don’t pull the tail wire forcefully during the use to avoid damage to the tail wire.
  13. Don’t beat and scrape the hand piece in a hurry.
  14. After using the device, power off the device and pull out the power plug.
  15. Our company specialises in producing medical devices and we’re responsible for its security only when the device maintained, repaired and modified by URIT or Distributor authorised by the our Company, and the replacement accessories are made by our Company and operating follow the user manual.
  16. The internal thread of the tips produced by some manufacturers is rough, rusty, chipped or adopts other standard threads. When used with the hand piece, it is easy to damage and slip the teeth, and even cause irreparable damage to the product. Please use the original tip.
  17. When the operator uses a different series of tips, it needs to adjust the working mode accordingly to avoid breaking the tip.
  18. Don’t move or flip the device during use.

Cleaning and sterilisation

Hand piece
When using alcohol for sterilisation, use 70%~80% (volume ratio) ethanol to soak a piece of clean dry gauze,and then use this gauze to wipe the surface to be sterilised twice for 3 minutes. Dry or wipe the residual alcohol with a clean, dry cloth.

Sterilisation

  1. Please sterilise at 135℃ temperature and 0.22MPa for 15 minutes by high pressure steriliser.
  2. Pull out the hand piece and remove the tip after each use.
  3. Wrap the hand piece with a disinfectant towel or bag.
  4. After sterilisation, the hand piece should be naturally cooled before use again to avoid scalding.

NOTICE:

  1. Before sterilisation, use compressed air to remove the cleaning fluid remaining in the hand piece.
  2. When sterilisation, ensure to remove the tip from the hand piece, and avoid mixing it with other instruments for sterilisation.
  3. When sterilisation, please always pay attention to whether the hand piece is damaged externally. Iris strictly forbidden to apply any protective oil on the surface of the hand piece.
  4. Steriliser parts can be sterilised at least 250 times
  5. It is strictly forbidden to sterilise the hand piece in the following ways
    • Put the hand piece in the solution and cook.
    • Soak the hand piece with disinfectant water such as iodine, alcohol, formaldehyde, etc.
    • Put it into the oven or microwave oven to bake at high temperature.

Tip
The tips can be sterilised in high temperature and pressure environment.

Torque wrench and Undo wrench

  1. Torque wrench and Undo wrench can be sterilised in high temperature and pressure environment.
  2. It is strictly forbidden to sterilise in the following ways:
    • Put it in the solution and cook.
    • Soak it with disinfectant water such as iodine, alcohol, formaldehyde, etc.
    • Put it into the oven or microwave oven to bake at high temperature.

NOTICE:
We will not be responsible for the damage to the torque wrench and undo wrench directly or indirectly caused by the improper use of the above methods.

Cleaning Tips, Torque wrench and Endo wrench
Tips, Torque wrench and Endo wrench can be cleaned by the ultrasonic cleaning machine.

Troubleshooting

Error Possible causes Solutions
Turn on the power switch, there is no indicator light on the panel Poor
contact of power plug Plug in the power plug tightly
Internal fuse not working Contact your local dealer or our company

There is no vibration or no water spray at the tip after stepping on foot switch| Poor contact of wired foot switch| Plug in the plug of foot switch tightly
Batteries are out of power  of wireless foot switch| Change new batteries
Foot switch not working| Match the foot switch again(please refer to paragraph 2.6)
After stepping on the foot switch, the tip does not vibrate but there is water spray at the tip| Tip loose| Fasten the tip using the wrench
---|---|---
Faulty handpiece| Pull out hand piece and contact your local dealer or our company
Faulty handpiece cord or inside circuit| Contact your local dealer or our company
There is water spray at the tip after power off| Faulty electromagnetic valve| Contact your local dealer or our company
Hand piece overheating| Spray is set up too small| Adjust the spray
Hand piece                 overheating seriously| Faulty hand piece| Pull out hand piece and contact your local dealer or our company
Inadequate amount of spray| Spray is set up too small| Adjust the spray
The water circuit is blocked| Unblock the water circuit by three-ways syringe
Weak tip vibration| Tip loose| Fasten the tip using the wrench
There is not dry between the base of the hand piece and its cord| Dry the connector between the base of the hand piece and its cord by hot air
Worn or bent tip| Replace the tip
Water is leaking between the base of the hand piece and its cord| Wear of the seal| Replace the seal
There is no vibration or noisy at root canal file| Loose clamping nut| Tighten clamping nut
Damaged root canal holder| Replace root canal holder

NOTICE: If the fault still cannot be resolved, please contact your local dealer or our company.

Storage, maintenance and transportation

Storage and maintenance

  • The device should be handled with care, far away from the earthquake source, and should be installed or store din a cool, dry and ventilated place.
  • Do not mix with toxic, corrosive, flammable and explosive materials during storage.
  • When the product is not used for a long time, it should be connected to water and electricity once a month, each time for 5 minutes.
  • Store temperature from -20 ℃ to 55 ℃,relative humidity ≤95%,atmospheric pressure from 70 kPa to 106  kPa.

Transportation

  • Transport should not be mixed with dangerous goods.
  • Avoid excessive shock and vibration during transportation, handle with care and avoid upside-down.
  • Keep away from rain, sunlight or snow during transportation.

Maintenance

Maintenance list as follow:

No. Name Specification/model
1 Main board /
2 Touch keyboard /
3 Hand piece /
4 Hand piece cord /
5 Tips /
6 Torque wrench /
7 Endo wrench /
8 Endo tips /
9 Liquid pipe 4mm×6mm
10 Power cord /
11 Electromagnetic valve /
12 Wireless foot switch /
13 Wired foot switch /

NOTICE: The manual does not exhaustively list the accessories and specifications of the DA-20. Please refer to therandom delivery materials and packing list for details.

After-sale service

This device is guaranteed by the warranty card from the date of sale, and is responsible for lifetime maintenance.Irreparable device damage caused by non- designated dedicated maintenance personnel is not covered by the free warranty.

Symbols description

Symbol Description Symbol Description
Trademark Fuse
Caution AA batteries
Refer to instruction manual/ booklet Manufacturer
Symbol Description Symbol Description
--- --- --- ---
“ON” (power) “OFF” (power)
This symbol indicates that the waste of electrical and electronic equipment

must  not be disposed as unsorted municipal waste and must be collected separately. Please contact an authorised representative of the manufacturer for information concerning the decommissioning of your equipment.
| Date of manufacture| | Use by date
| Temperature Limit| | Atmospheric pressure limitation
| Humidity limitation| | Serial number
| This way up| | Fragile, handle with care
| Keep away from rain| | CLASS II equipment
| Type B applied part:The applied part is not conductive to the patient| | Medical device
| Sterilisation at 135℃ inan autoclave| | Connection of the foot switch
---|---|---|---
Liquid| Slider for changing liquid flow rate| Power| Slider for changing power scale
| Slider regulation direction| IPX1
IPX4| Ingress protection rating
| Do not roll| | Stacking limit by number

Environmental Protection

Name Toxic and harmful substances or elements
Pb Hg
Hand piece component O
Valve component O
Plastic shell O
Liquid pipe and joint O
Circuit board O
Name Toxic and harmful substances or elements
--- ---
Pb Hg
Stamping parts O
Switch O
Cord O
Tips O
Foot switch O

The table is compiled in accordance with the provisions of SJ/T 11364. O: It means that the content of this toxic and hazardous substance in all homogeneous materials of this part is below the limit requirement of GB/T 26572.
X: It It means that the content of the toxic and hazardous substance in at least one of the homogeneous materials of the part exceeds the limit requirement of GB/T 26572.(This product complies with the requirements of EU RoHS environmental protection: currently there is no mature technology in the world that can replace or reduce the lead content in electronic ceramics, optical glass, steel and copper alloys)In accordance with Administrative Measure son the Restriction of the Use of Hazardous Substance sin Electrical and Electronic Products, Regulation son the Management of the Recycling and Disposal of Waste Electrical and Electronic Products and related standards, please observe the safety and use precautions of the product, and recycling or disposal of this product please apply appropriate measures in accordance with local laws and regulations after the product is used.

Manufacturer’s rights

The company reserves the right to modify the design, technology, accessories, user manual content and packing list content of the product at any time without notice. In case of discrepancies, the actual product shall prevail.

Electromagnetic compatibility

NOTICE:

  1. Without the express consent of URIT, unauthorised changes or modifications to the device may cause electromagnetic compatibility(EMC) problems of the device or other device.
  2. The design and test of device comply with the operating regulations related to EMC.
  3. WARNING:Even if other devices meet the launch requirements of the corresponding national standards,the device or system may interfere with other electronic devices.

Cable length

Cable name Type Length
Power cord Shielded parallel line 1.8 m
Input line of foot switch Shielded parallel line 2.5 m
Hand piece cord Shielded parallel line 2 m

Key components of EMC
The product key components of EMC are the scale’s main board chip, touch board chip, transformer and diaphragm pump. The use or replacement of accessories, cables, transducers, etc. that are not designed to match will cause the electromagnetic emissions and immunity performance to be significantly reduced.Do not replace device parts without authorisation.

Electromagnetic emissions

GUIDANCE AND MANUFACTURER’S DECLARATION- ELECTROMAGNETIC EMISSIONS

DA-20 is designed for use in the electromagnetic environment described in the table below. The user or purchaser must ensure that the medical device is used in the environment described below.
Emissions Test| Compliance| Electromagnetic environment – guidance
RF emissions GB 4824| Group 1| DA-20  uses  radio frequency  energy  for  its internal  operation.  Consequently,  its radio frequency emissions are very low and are not likely to create any interference with other nearby equipment.
RF emissions GB 4824| Class B| DA-20 is suitable for use in all establishments, including domestic and those directly connected to the low voltage energy supply public network supplying buildings used for domestic purposes.
Harmonic emissions GB 17625.1| N/A
Voltage fluctuation and flickers GB 17625.2| Conforming

Electromagnetic immunity

GUIDANCE AND MANUFACTURER’S DECLARATION- ELECTROMAGNETIC IMMUNITY

DA-20 is designed for use in the electromagnetic environment described in the table below. The user or purchaser must ensure that the medical device is used in the environment described below.
Immunity test| IEC 60601 test level| Conformity level| Electromagnetic environment – guidance
Electrostatic discharge (ESD) GB/T 17626.2| ±6 kV contact
±8 kV air| ±6 kV contact ±8 kV air| Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, relative humidity should be at least 30%.
Electrical fast transient/burst GB/T 17626.4| ±2 kV for power supply lines ±1 kV for input/output lines| ±2 kV for power supply lines ±1 kV for link cable| ** Main power quality should be that of a typical commercial or hospital environment.
Surge GB/T 17626.5| ±1 kV differential mode
±2 kV common mode| ±1 kV differential mode| Main power quality should be that of a typical commercial or hospital environment.
---|---|---|---
Voltage dips, short interruptions and voltage variation son power supply input lines.GB/T 17626.11| <5%UT (>95%dip in UT) for 0.5 Cycle
40%UT (60%dip in UT) for 5 Cycles
70%UT (30%dip in UT) for 25 Cycles
<5%UT (>95%dip in UT) for 5 seconds| <5%UT (>95%dip in UT) for 0.5 Cycle
40%UT (60%dip in UT) for 5 Cycles
70%UT (30%dip in UT) for 25 Cycles
<5%UT (>95%dip in UT) for 5 seconds| Main power quality should be that of a typical commercial or hospital environment. If the user of DA-20 requires continued operation during power main interruptions, it is recommended that the DA-20 be powered from an UPS or battery supply.
Power frequency (50-60 Hz)magnetic field GB/T 17626.8| 3 A/m| 3 A/m| Power frequency  magnetic  fields  should  be  at  levels characteristic of a typical location in a typical commercial or hospital environment.
NOTE:** UT is the A.C. mains voltage prior to applications of the test level.

Electromagnetic immunity

GUIDANCE AND MANUFACTURER’S DECLARATION- ELECTROMAGNETIC IMMUNITY

DA-20 is designed for use in the electromagnetic environment described in the table below. The user or purchaser must ensure that the medical device is used in the environment described below.
Immunity test| IEC 60601t est level| Conformity level| Electromagnetic environment – guidance
Conducted RF| 3 Vrms| 3 Vrms| Portable and mobile RF communications equipment should be used no closer to any part of DA-20, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.Recommended separation distance d
Where P is the maxi mum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).Field strengths from fixed RF transmitters, as determined by an electromagnetic  site  survey,a   should  be  less  than  the compliance level in each frequency range.
---|---|---|---
GB/T 17626.6| 150 kHz~80 MHz| 3 V/m
Radiated RF| 3 V/m
GB/T 17626.3| 80 MHz~2.5 GHz
NOTE 1 – At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2- These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.a.
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephone and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the DA-20 is used exceeds the applicable RF compliance level above, DA-20 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating DA-20.Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND DA-20

RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND DA-20

DA-20 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of DA-20 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and DA-20 as recommended below, according to the maximum output power of the communications equipment.
Rated maximum output power of transmitter W| Separation distance according to frequency of transmitter M
150 kHz~80 MHz
| 80 MHz~800 MHz
| 800 MHz~2.5

0.01| 0.12| 0.12| 0.23
0.1| 0.38| 0.38| 0.73
1| 1.2| 1.2| 2.3
10| 3.8| 3.8| 7.3
100| 12| 12| 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.NOTE 1 – At 80 MHz and 800 MHz, the higher frequency range applies.NOTE 2 – These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.

DA-20 has passed test according to the standard YY 0505-2012 and standard IEC 60601-1-2:2004, but it cannot guarantee in any way that it is not affected by electromagnetic interference. DA-20 should be avoided using in high electromagnetic environments.

Index:Table of tip power for use

Model Gear Irrigation flow Treatment type
G1 1-10(G) YES Supranational scaling
G2 1-10(G) YES Spur vaginal scaling
G4 1-6(G) YES Supranational scaling
P1 1-10(P) YES Submarginal scaling
P3 1-10(P) YES Submarginal scaling
E1 1-3(E) YES Root canal washing
E3D 1-3(E) YES Root canal washing
E14 1-3(E) YES Root canal washing

References

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