Hulaser K Series User manual

1370
Publishing date: Jan.02.2020
Document No: PK2M-02
En

COPYRIGHT
This user manual is proprietary to Hulaser, and is protected by copyright.
No information contained herein may be copied, translated, transcribed or duplicated for any commercial
purposes or disclosed to the third party in any form without the prior written consent of Hulaser.
© 2020 Hulaser, Inc. All rights reserved.
This user manual should be read and used as a guideline for properly installing and operating the device.
If you have any questions concerning the contents of the manuals, contact our company at the following
address or phonenumber.
Address: 1110, DAERUNG TECHNOTOWN 17,25, GASAN DIGITAL 1-RO, GEUMCHEON-GU, SEOUL 08594,
KOREA.
Tel: [phone]
Homepage: http://www.k2lasers.kr

TABLE OF CONTENTS
1. Safety information
1-1. Safety information
1-2. Precaution
2. Product overview
2-1. Unpacking
2-2. Components
2-3. Specifications
2-4. Product Layout
2-5. Clinical Use
3. Cleaning andsterilization
3-1. Cleaning and Disinfection
3-2. Sterilizing
4. Charging
4 6-2. Starting the device 22
6-3. Selecting the procedure 22
4 6-4. Function settings 24
6 6-5. Custom settings 25
7 6-6. Presets settings 26
6-7. Tip initiation 28
7 6-8. Firing the laser 29
8 6-9. Turning off the laser 30
10 6-10. Calibrating the laser 30
11
12 7. Maintenance 31
13 7-1. DISPOSAL 31
7-2. Regular maintenance 31
13
14 8. Troubleshooting and repairs 33
15 8-1. Troubleshooting 33
8-2. Malfunctions andError messages 33
5. Installation
5-1. Installing the battery and Tip
(Including the tip cap)
5-2. Adjusting the Tip length
5-3. Stripping the Tip jacket
5-4. Cleaving the Tip
6. Operating
6-1. Preparation
17 8-3. Repairs 33
17
9. Label 34
19 9-1. Labels Description on the package 34
19 9-2. Labels Description on the device 35
20 9-3. Labels location 37
21 10.Limited Warranty 38
21

1. SAFETY INFORMATION
The purpose of the safety information is to ensure the safety of users and prevent property
damage. Please read this document carefully for proper use.
1-1. Safety information
Danger
DANGER indicates a hazardous situation which, if not avoided,
could result in serious injuries.
● Pointing the beam directly to the eyes may cause damage to the eye. Do not
use it close to the eyes of people orpets.
● Do not use the device in potentially explosive environments and flammable apparatuses
or oxidizing gases such as nitrous oxide(N
2
O) and oxygen(O
2
). When using flammable solutions
or adhesives for cleaning and disinfecting, be aware of the ignition of gases.
Warning
WARNING indicates a hazardous situation which, if not avoided,
could result in moderate or minor injuries.
● When the device is not working properly, stop using thedevice.
● Thefibertip is supplied in non-sterileandmust be sterilizedbefore use.Follow thesterilizing
instruction according to the chapter3.
Caution
CAUTION indicates a hazardous situation which, if not avoided,
could result in moderate or minor injuries.
● Doctor, assistant and all others inside the operatory must wear the laser protective eyewear for the
laser wavelength of 980nm. The patient completely covers the eyes with a cloth. If not, wear goggles
and close your eyes. The laser protective eyewear needs to be inspected periodi- cally for your safety.
● Do not point the laser beam to metallic or reflective objects like mirrors as the laser may reflect and
cause a hazardous situation.
● Do not look directly into the beam, laser aperture or at specular reflections.
Never direct or point the beam at anyone’s eyes.
This must be followed even when wearing safety goggles.
Likewise, do not look directly into the laser or point it at others' eyes while wearing safety goggles.
4

● Doctor, patient, assistant and all others inside the operatory must wear
appropriate laser eyewear protection for the laser wavelength of 980nm.
Periodically inspect laser eyewear for pitting and cracking. For replacement or additional protective laser
eyewear, please contact Hulaser or your authorized dealer.
● A hazardous radiation exposure may happen during the procedures.
● Installing and operating the device should be followed by CAN/ CSA-Z386-92:Laser safety in
health care facilities.
● Usethe appropriate power supplyand power plugwith the charger. Using incompatible power
supply and power plug can cause serious injuries or damage to the device.
● Donotconnect the power supply into the damaged sockets. Unsecured connections can cause
electric shock or fire.
● Handle and dispose the lithium ion batteries with care. Handling by inadequate persons may cause
a hazard such as excessive temperatures, fire orexplosion.
● Be aware of infection by the laser plume during the laser procedure which can be generated while
vaporizing virally or bacterially infected tissue. To prevent the infection, wear the protective masks
and use the high speed suction.
● Use of controls or adjustments or performance of procedures other
than those specified herein may result in hazardous radiation exposure
Warning
No modification of this equipment is allowed.
Warning
Do not modify this equipment without authorization of the manufacturer.
Warning
If this equipment is modified, appropriate inspection and testing must be conducted to
ensure continued safe use of equipment.
[Note]
In the event of an accident, the incident must be reported to a HULASER, Inc. or
a European representative or the competent authority.
5

1-2. Precaution
● This device must be purchased by an authorized person like a dentist, physician.
● This user manual must be understood to the user who is licensed before using this device.
● Adjust the device’s setting based on your clinical experience. Start the laser treatment from the
lowest level and increase gradually. And monitor the results of the treatment and define the clinical
parameters, and then make appropriate settings for any specific treatments.
● The device’s heat may occur a burn on tissue. Start the laser treatment from the lowest level and
increase gradually. Be careful of nerves and blood vessels not to be damaged while using this
device. Do not point the laser towards hard tissues such as tooth or bone or any metallic
restorations. Exercise extreme caution when using this laser inside the gingival pocket, 3rd molar
sockets and other openings where visibility is limited.
● Anesthesia might not be required for treating soft tissue, but monitoring on patients is necessary to
check that they feel any pain or discomfort. If they do, anesthesia might be needed or stop
treatment if required.
● Consider the patient medical history and risk prior to thetreatment.
● Prepare anysituationforgeneralmedicalconditionsthat mightcontraindicatealocalprocedurefor
a patient such as allergy to local or topical anesthetics, heart disease, lung disease, bleeding
disorders, and immune system deficiency, or any medications that may contraindicate use of
certain light/laser type sources using this device. The opinion from patient physician is
advisable prior to the clinical treatment.
● Consider the side effects such as transient discoloration of the tissue surface or discomfort while
recovery.
6

2. PRODUCT OVERVIEW
2-1. Unpacking
When unpacking the shipping package, check that any components are damaged or missing. Contact the
Hulaser Service Representative immediately for any damage or missing.
[Note]
The shipping container might be needed when you return the device to the Hulaser Service Representative
for repair.
7

2-2. Components
Description
Model
No.
Picture
K2 Mobile battery charger
and cradle
K2 Mobile battery charger
1
AC/DC Adapter
TRG30R050V
1
K2 mobile Main body
K2 Mobile
1
Thin Tip for K2 Mobile
MET
1
General Tip for K2 Mobile
MGT
2
Fiber stripper
Fiber stripper
1
8

2-2. Components
Description
Model
No.
Picture
K2 Rechargeable Battery
KL2-0006
2
Laser protective eyewear
Model: 0282
890~1070nm
: D LB6+I LB7+RM LB8, OD 6-8
2
User manual
PK2M-02
1
w arning
Use of accessories, adapter other than those specified or provided by the manufacturer of this
equipment could result in increased electromagnetic emissions or decreased electromagnetic
immunity of this equipment and result in improper operation.
Warning
Portable RF communications equipment (including peripherals such as antenna cables and
external antennas) should be used no closer than 30 cm (12 inches) to any part of the K2
MOBILE, including cables specified by the manufacturer.
Otherwise, degradation of the performance of this equipment could result.
9

2-3. Specifications
● Classifications
MFDS Device
Class III Laser Surgical Unit : Diode
CE Device
Class IIb Medical Device
FDA Device
79GEX Class II Medical Device
CDRH Laser
Class IV (4) Laser
● Charging Station
Size(WxDxH)
160mm x 90mm x 38mm
Weight
150 g
Voltage Input
100~240V, 47~63Hz
Battery
Lithium Ion 3.7 V 1700 mAh
Recharge Time
(When fully discharged)
3hours
● Main Body
Size(L x D x H)(without tip)
205mm x 25mm x 30mm
Weight (with battery)
Laser
135g
Medium
GaAlAs
Wavelength
980nm±10nm
Max output power
3.5W(CW)
Max peak power
6.0 W(pulse)
Emission mode
CW/Pulse mode
Aiming Beam
635nm Laser diode, max5mW
Pulse mode
CP1
Pulse width
On, off Time 50ms ±10%
Pulse repetition rate
10Hz
CP2
Pulse width
On, off Time 5ms ±10%
Pulse repetition rate
100Hz
Temperature
Operating
10 ℃ –40 ℃
storing
0 ℃ –50 ℃
Humidity
Operating
30 –75 % (non-condensing)
storing
10 –90 % (non-condensing)
Pressure
Operating
700hPa~1060hPa
storing
700hPa~1060hPa
Rate operating altitude
≤3000m
10

2-4. Product Layout
All the names of devices must be understood before read this user manual.
● Device
This device is used for a variety of dental soft tissue treatments. Laser diode is used as a source of
invisible infrared radiation for this device and delivered to the treatment area through the Tip.
● Charging Station
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Battery

The charging indicators on the front of the charging station display the charging status.
-Up to four batteries are able to be charged at one time.
-If one battery is fully charged, the indicator turns blue half-round.
-If the indicator doesn’t turn half-round after charging for more than three hours, the battery might be damaged
and need to be replaced.
[Note]
Clean the charging station with a dry cloth gently. Avoid using wet wipes.
2-5. Clinical Use
● Dental soft tissue indications
Suchas incision, excision, vaporization, ablation and coagulation of oral soft tissues including
marginal and inter-dental gingival and epithelial lining of free gingiva
Including <Gingivectomy>, <Operculectomy>, <Vestibuloplasty>, <Frenectomy>, <Fibroma Removal>,
<Incision and Drainage>, <Papillectomy>
● Laser implant procedures
Including <Implant Recovery>, <Gingival Trimming>, <Peri-Implantitis>, <Laser Osseointegration>
● Laser endodontic procedures
Including <Root Canal Sterilization>, <Pulpotomy>, <Direct Pulp Capping>, <Apical Abscess Treatment>
● Laser periodontal procedures
Including <Post scaling>, <Laser Curettage mild>, <Laser Curettage moderate>, <Laser Curettage
severe (removalofdiseased,infected,inflamedandnecrosedsofttissuein theperiodontalpocketto
improve clinical indices including gingival index, gingival bleeding index, probing depth, attachment
loss and tooth mobility)>
● Others procedure
<Gingival Depigmentation>, <Laser Troughing>, <Aphthous-Ulcer>, <Hypersensitivity>, <Hemostasis>,
<BactericidalEffect>,<ToothWhitening>, <Biostimulation>, <OrthodonticPain Relief>,<TMJ(Temporo-
mandibular Joint Pain Relief)>, <LaserSedation>
12

3. CLEANING AND STERILIZATION
3-1. Cleaning
The device must be cleaned prior to use on every patient. Use dry gauze on the device’s surfaces that are
exposed to contaminant.
To clean the main body, follow the instruction:
1. Ensure that the device is turnoff.
2. Wear protective gloves and eyewear when handling the contaminated main body.
3. Remove and the FrontCap.
4. Remove the usedTip.
5. Remove the battery from the mainbody.
6. Wipe the main body with cotton gauze.
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3-2. Sterilizing
The Tip must be sterilized in an autoclave before use.
Warning
Although the recommended autoclave sterilization procedure is specified by Hulaser, users
have a responsibility to validate the autoclave sterilizer properly.
[Note]
The recommended autoclave cycle:
Temperature: 250℉(121℃) | Time cycle: 20 minutes
* Conducted for the steam sterilization method and the sterilization assurance level in the test was
not less than 10 killed organisms in one cycle.
Maximum number of cycles: 20
Warning
After 20cycles of Tip, User Must replace Tip with new one.
To sterilize the Tip, follow the instruction:
1. Individually places the Tip inside pouches.
2. Removeautoclavetrayand put pouches onthetray.
3. Place the tray in the autoclave chamber and sterilize.
4. When the autoclave cycle is complete, remove the tray and let the Tip cool and dry.
There are no specific requirements for the drying time. Drying of the Tip is suggested for better
handling only.
5. The Tip is now ready foruse.
14

4. CHARGING
You must charge the batteries before using the device. Follow the instructions to charge the batteries.
Caution
Use only Hulaser-approved power adapter.
[Note]
● Place the charging station on a surface not to be interfered or contaminated.
● When charging for the first time, charge the batteries for at least three hours.
● The laser cradle is not for charging but for keeping the device when not in use.
15

1. Plug the power adapter into an AC outlet and connect it to the charging station as below.
2. Open the cover of the charging station.
3. Place the batteries into the battery container in eitherorientation.
4. When the charging indicator turns blue, the battery is charging.
16

5. INSTALLATION
You must install the battery first and then Tip properly as the following instructions before use the device.
5-1. Installing the battery and Tip (Including the Front Cap)
1. Open the battery cover and insert a battery into the socket at the end of the mainbody.
To remove a battery, open the battery cover and gently pull out the battery from the socket.
2. Detach the Front Cap from the front of the mainbody.
3. Move the slide bar forward until it doesn’t move anymore.
[Note]
When the front cap and tip are removed, the laser is emitted from where the tip was connected.
If only the front cap is mounted without the tip, the laser is emitted through the front cap
from where the tip was connected.
17

4. Insert Tip into the front of the main body until the magnet inside the main body holds the Tip.
5. Secure the Front Cap to the main body passing through the fiber carefully.
6. Check that the cannula comes out straight from the main body as below. If it comes out bended
or the Tip is encumbered, straighten the cannula and re-install the FrontCap.
If the Front Cap is installed properly, you may adjust the cannula
length for the appropriate procedure. You may bend the Front Cap
up to 70°for your convenience.
Caution
Donotseparatethe Front Capwhile it is bent.The Tip may break.When separating the
Front Cap from the main body, hold the Tip cap straight and then remove.
18

5-2. Adjusting the Tip length
You can adjust the Tip length for the procedure appropriately.
To extend the Tip, move the Tip handle forward.
To shorten the Tip, move the Tip handle backwards.
If you move the sliding bar back and forth by force, the rail of the sliding bar might be damaged.
5-3. Stripping the Tip jacket
The laser retains debris from thetissues ontheTipso when the blackenedTip extends theTipshaft,
cleave the Tip and strip the jacket using the Tip stripper and cleaving tool to prepare a new
Tip for the next procedure.
1. Adjust Fiber stripper core size to 40. 2. Insert the Tip into the Fiberstripper.
3. Grab and hold the Fiber stripper and 4. Pull the Tip out gently from thestripper
grasp the Tip in the other hand. to remove the jacket around 6 to 10mm.
19

5-4. Cleaving the Tip
As the Tip deteriorates, it might cause the fracture. Cleave the discolored Tip using the cleaver.
1. Put the cleaver at approximately 3-5 mm from the previous cleave to remove the discoloredTip.
2. Engrave a line across the surface of the Tip using the cleaver lightly.
3. Break the Tip against the cleave holding the Tip with two hands.
Pointthe device at a rightangle to a white paper holding it approximately 10mm from the paper,
and then set the laser in Ready mode.
If the red circle is clear, the Tip has been cleaved right.
If the red circle is not clear, cleave the Tipagain.
20