Pioon S3 User manual
Medical Diode Laser
USER MANUAL
Model: S3
Wuhan Pioon Technology Co.,Ltd.
Version: V1.5
All rights reserved.
Revision Date: JUNE 15, 2021
USER MANUAL Page 2 of 92
Instructions Before Use
When receiving this product, please carefully check the integrity of the packaging.
Refer to the packing list and carefully check the product components and their
quantity. If there is any packing damage, equipment damage or component missing,
please contact our after-sales personnel or designated dealer for replacement.
In order to be better served, please confirm the packaging is in good condition and
check the product set, fill out the product receipt, the user file form and training
records, and promptly return to the company.
It is strongly recommended that users receive related training before use.
Contact your Sales Representative and make sure your training is scheduled.
Carefully read the instructions and do the relevant security measures in the
course of use to avoid the damage on the human body and equipment that may
be caused by the possible harmful laser radiation.
The company will not be liable for any personal injury or damage to equipment
caused by the failure to follow instructions during use.
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CONTENTS
1 GENERAL........................................................................................5
1.1 User Guide............................................................................................................... 5
1.2 Introduction............................................................................................................. 8
1.3 Indication................................................................................................................. 9
1.4 Intended User....................................................................................................... 10
1.5 Intended Population............................................................................................10
1.6 Contraindications................................................................................................ 10
1.7 Purchase of Fibers &Tips..................................................................................13
2 SAFETY PRECAUTION............................................................. 14
2.1 Proper Use.............................................................................................................14
2.2 Safety Instructions.............................................................................................. 16
2.3 Laser System Safety Features......................................................................... 20
2.4 Clinical Precautions for Laser Safety............................................................ 22
3 PRODUCT DESCRIPTION........................................................ 24
3.1 System Description.............................................................................................24
3.2 Product Specifications.......................................................................................27
3.3 Storage and use of the environment..............................................................28
3.4 Laser Beam Delivery...........................................................................................28
4 INSTALLATION............................................................................ 30
4.1 Installation Instructions..................................................................................... 30
4.2 Unpacking..............................................................................................................30
4.3 Installation............................................................................................................. 30
4.4 Packing and Transporting................................................................................. 34
4.5 Power Description............................................................................................... 35
4.6 Software installation and upgrade..................................................................36
5 FIBER AND HAND PIECE......................................................... 37
5.1 Single Use Tips.................................................................................................... 37
5.2 Assembly of the hand piece............................................................................. 39
5.3 Disconnecting the Fiber and Tip..................................................................... 40
5.4 Assembly of Disposable Fiber Tips on Optional Fiber Hand Piece.......41
5.5 Post Procedure.................................................................................................... 43
5.6 Structure of an Optical Fiber............................................................................ 43
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5.7 Stripping the Fiber...............................................................................................45
5.8 Cleaving the Fiber............................................................................................... 46
6 DISINFECTION.............................................................................49
7 OPERATION PROCEDURE.......................................................52
7.1 Preparations..........................................................................................................52
7.2 System boot.......................................................................................................... 52
7.3 Use instructions for customized management regimens........................ 53
8 TROUBLESHOOTING................................................................ 73
8.1 Reminding Type................................................................................................... 73
8.2 Reminding mode..................................................................................................73
8.3 Reminding function.............................................................................................75
8.4 Reminding system detection............................................................................76
8.5 Fault Diagnosis and Analysis...........................................................................76
9 MAINTENANCE........................................................................... 78
9.1 Daily maintenance............................................................................................... 78
9.2 Routine Inspection.............................................................................................. 79
9.3 Post Procedure Cleaning.................................................................................. 79
9.4 Cleaning of the Main Unit.................................................................................. 80
9.5 The maintenance for long-term storage........................................................81
9.6 Power calibration.................................................................................................81
10 ELECTROMAGNETIC COMPATIBILITY.............................. 82
10.1 Components information................................................................................ 83
10.2 RF Transmitting..................................................................................................84
10.3 IMMUNITY TEST LEVELS................................................................................ 84
11 WASTE DISPOSAL................................................................... 89
12 SERVICE..................................................................................... 90
12.1 Quality Commitment.........................................................................................90
12.2 Disclaimer Clause............................................................................................. 90
13 CONTACT....................................................................................92
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1 GENERAL
1.1 User Guide
Requirement
Read these instructions before the initial start-up to prevent misuse and damage.
1.1.1 LABELS and SYMBOLS
Product identification and packaging instruction are in line with IEC 60825-1:2014,
EN ISO 15223-1:2016 and other related requirements. Product identification and
packaging used in graphics and in symbols are as follows:
Graphics / symbols
Meaning
Position
See the section Warning
and Informational Signs
Operators Manual
Important information for
users and technicians
Operators Manual
IPX0
The degree of enclosure
protection against harmful
ingress of water
Operators Manual
Optical Fiber
&
Laser aperture
&
Laser Danger
Back side of the main unit
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Graphics / symbols
Meaning
Position
Class 4 laser product
explanatory
&
Remote interlock
&
Laser output and
standard informatioin
Back side of the main unit
Emergency Laser Stop
Right side of the main unit
Pull the handpiece up
Right side of the main unit
Product nameplate
Left back side of the main
unit
Serials number
Nameplate
Refer to instruction
manual
Nameplate
Manufacture date
Nameplate
Manufacturer
Nameplate
Type B applied part
Nameplate
Non-recyclable
Nameplate
European Representative
Nameplate
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Graphics / symbols
Meaning
Position
CE Marking
The position is on the
Nameplate
Indicates the connection
for a foot switch
On the connecting wire of
the foot switch
Fragile, be careful
The position is on the
outer package
Keep Dry
The position is on the
outer package
Transport should be
upright
The position is on the
outer package
Temperature Limitation
The position is on the
outer package
Keep away from direct
sunlight
The position is on the
outer package
The medical device is not
made with latex
The position is on the
outer package
The range of humidity to
which the medical device
can be safely exposed
The position is on the
outer package
The range of atmospheric
pressure to which the
medical device can be
safely exposed
The position is on the
outer package
Do not use if package is
damaged
The position is on the
outer package
Lithium Battery Hazard
Symbol
The position is on the
outer package
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Graphics / symbols
Meaning
Position
Recycle Lithium-Ion
Battery. Do not dispose
with common waste.
Battery
1.1.2 Target group
This document is for dentists and office personnel.
1.2 Introduction
The S3 is a portable laser product designed for oral medical laser surgery. This
device is for Professional Use Only and its surgery uses shall only be administered
by or under the supervision of a trained professional. The product is dedicated to
clinicians and patients with a safe and effective treatment experience.
The Medical Diode Laser uses Galium Aluminum Arsenide (GaAlAs) diode lasers as
energy source. The laser energy is delivered to the surgical area by an optical path
transmission system consisting of a flexible fiber connecting the laser source and
hand piece.
The surgical diode laser produces wavelengths at approximately 980 nanometers
(nm) in pulse and continuous mode. The light is both a visible aiming and an
invisible non-ionizing thermal radiation that does not create changes in cellular DNA.
The laser radiation is absorbed by the tissue under management and is converted to
heat. The heat is used for cutting, coagulation, germ reduction and desensitization.
The S3 unit is an air-cooled device consisting of a closed loop, liquid filled, heat pipe
thermal transfer system with fan and air assistance. Heat is transferred to the
system and dissipated across a framework of fins where it is released to the ambient
atmosphere. Please choose a well-ventilated location for equipment installation. The
placement platform requires a hard texture and shall not impede the air flow of the
bottom of the equipment. Keep the device at least 20cm away from the wall or other
equipment to facilitate the operation of the power switch.
For safety, the diode features several ways to stop energy flow to deactivate the
laser. The safety system includes a choice of an emergency shutdown button, a foot
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switch, a power switch on the main unit, and a remote door interlock. Any of these
features can be used to shut down the laser.
All persons present during the use of the medical laser shall wear protective eyewear.
All laser safety eyewear have a specific wavelength range which is indicated on the
lens or eyepiece. Care must be taken to assure that the eye protection is correct to
the appropriate laser radiation. Protective eyewear is marked with optical density >2
at 650nm and >5 at 980nm wavelength.
The user needs to carry out appropriate clinical and technical training before using
this product and shall follow the instruction manual during the operation of the device.
Before use, doctors should choose the reasonable management parameters
according to the patient's condition.
1.3 Indication
The S3 Medical system is suitable for the following indications:
450nm:
Oral soft tissue surgical.
650nm:
Periodontitis;
Dentine hypersensitivity (DH).
980nm:
Oral soft tissue surgery;
Periodontal treatment;
Root canal therapy/treatment;
Dentine hypersensitivity (DH).
Note
The manufacturer assumes no responsibility for the direct effects or side
effects that arise from therapeutic or surgical use of the system. The sole
responsibility lies with the medical personnel. Wuhan PIOON Technology
Co., Ltd. (PIOON) assumes no liability for any damage caused by improper
use or non-compliance with the instructions for use provided in this manual.
The sole responsibility lies with the medical personnel.
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980nm Symptoms：
Pyogenic granuloma ; benign hyperplastic tumors; frenectomy; implant exposure ,
periodontitis ; endodontic disinfection ; gingival maxillary frenum ; root canal
therapy/treatment ; Dentine hypersensitivity (DH).
1.4 Intended User
Professional users under prescription use only. The medical laser device is intended
for the use in the field of dentistry by trained and qualified personnel.
1.4.1 Usage Perquisites
Every clinic and hospital utilizing this device is encouraged to adopt a Laser Training
and Safety Program.
If there are any questions or needed assistance during the use, please contact the
designated dealer or our company for after-sales support.
1.5 Intended Population
Male and female patients adolescence through adult.
1.6 Contraindications
Precancerous lesions, acute hemorrhagic diseases, thyroid diseases, active
bleeding, cardiopulmonary renal failure, wound healing dysfunction, coagulation
disorders, pregnant women, lactating women are banned.
Note
It is not recommended to use the product for a purpose for which it was not
intended.
Note
The S3 medical laser device is to be used by dental physicians and trained
associates under medical supervision. Clinical decisions regarding the
suitability of the device and the selection of the corresponding management
methods are exclusively the responsibility of the clinician.
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All clinical procedures performed with S3 must be subjected to the same clinical
judgment and care as with traditional techniques. Patient risk must always be
considered and fully understood before clinical management. The practitioner must
completely understand the patient’s medical history prior to the procedure. Exercise
caution for general medical conditions that might contraindicate procedure.
1.6.1 Absolute Contraindications
Do not shine laser light directly into the eyes, with or without eyewear
protection.
Do not apply the laser on patients with active cancer.
Do not apply to patients who suffer from photodermatoses as well as
photosensitised patients (photoallergies).
Note
The manufacturer assumes no responsibility for the direct effects or side
effects that arise from therapeutic or surgical or use of the system. The sole
responsibility lies with the medical personnel.
Do not apply the laser directly over the thyroid gland.
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1.6.2 Relative Contraindications
Do not apply the laser to patients who are taking drugs that have heat or
photosensitivity contraindications.
Do not apply the laser over areas recently injected with corticosteroids.
Do not apply the laser when individual intolerance of the procedure is
noted.
Do not apply the laser over a hemorrhage or active bleeding.
Do not use the laser on patients with meningitis or encephalitis.
1.6.3 Warnings and Precautions
For medico-legal reasons, the practitioner should know the patients’ medical history
and must weigh the benefit versus risk when providing laser procedures.
Use caution when applying the laser over areas where sensory perception is
absent or diminished.
Use caution when applying the laser to patients who are sensitive to light
exposure.
Use caution when applying the laser to patients who have heart or
pulmonary disease.
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Use caution when applying the laser to patients taking blood thinners or who
have hemorrhagic disorders.
1.7 Purchase of Fibers &Tips
Users are recommended to purchase and use quartz fiber and Tips that can transmit
wavelengths from 450nm to 980nm. Optical fibers within these specification are
suitable for the transmission of energy and various wavelength signals from visible
red to infrared. These affordable optical fibers provide an excellent optical
transmission performance are biocompatible, are high intensity, high reliability and
have a high laser damage threshold. The recommended fiber optic core diameters
can be found in the parameter specification section of Chapter 3 of this manual. For
the fiber optics and Tip categories, refer to Chapter 3, Component of this manual. For
notes on the use of optical fibers, refer to the Chapter 5 of this manual.
Note
The manufacturer assumes no responsibility for the direct effects or side
effects that arise from therapeutic or surgical use of the system. The sole
responsibility lies with the medical personnel.
Note
The S3 medical diode laser device is not provided with hand piece and
TIPS.Users are required to purchase the hand piece and TIPS
separately.Before acquiring and use of fiber optics,please read carefully
and follow the company’s recommendations for fiber optic material,core
diameter,and transmission band.Use of not recommended fiber optic
material may lead to abnormal laser output!
Fiber,hand piece and TIPS exposure to oral soft tissue may present
biological risks to the patient.It is advisable to purchase the products that
have passed Certificate of Conformity (CE) or Food and Drug
Administration (FDA) certification and reduce the biological risks that may
occur during the procedure.
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2 SAFETY PRECAUTION
2.1 Proper Use
The diode laser is a Class 4 laser system. The user must ensure that the device
works properly and is in a satisfactory condition before each use.
"Proper use" includes following all the instructions for use and ensuring that all
inspections and service tasks are performed.
Apply and meet the underlying guidelines and /or national laws, national regulations
and the rules of technology for medical devices applicable for startup and use of the
PIOON products for the intended purpose.
The user must observe the following:
only use properly operating equipment;
protect himself or herself and third parties from danger;
avoid contamination from the product.
During use, national legal regulations must be observed, in particular:
the applicable health and safety regulations.
the applicable accident prevention regulations.
To guarantee constant readiness for use and maintenance of value of the PIOON
product, the recommended servicing and safety inspections shall be adhered to:
Authorised to repair and service the PIOON product:
Technicians from the PIOON or its branches who are trained to deal with the
product.
The technicians of the PIOON franchised dealers specifically trained by PIOON.
The person responsible for the device and the user of the device must operate their
devices in accordance with the provisions of Medical Device Regulations.
USER MANUAL Page 15 of 92
Reference Servicing Section of this manual.
Information on electromagnetic compatibility
Disposal
Note
The product must be cleaned and serviced according to instructions found
in the Maintenance and Service Sections of this manual if it is not to be
used for a long period of time.
Note
Only those accessories may be used that are approved for the device.
Note
Based on IEC 60601-1-2 concerning the electromagnetic compatibility of
electromedical devices, we need to point out that:
Medical electrical devices are subject to special measures regarding
electromagnetic compatibility and must be operated in accordance with
PIOON assembly instructions.
Portable and mobile high-frequency communications devices can
influence medical electronics.
Damage from unsuitable accessories
The use of other accessories, transformers and lines than those indicated
(with the exception of transformers and lines that PIOON sells as
replacement parts for internal components) can increase transmission or
reduce the electromagnetic immunity of the product.
Only use accessories recommended by PIOON.
Note
PIOON cannot guarantee that accessories, lines and transformers not
delivered by PIOON.
PIOON will correspond with EMC requirements of IEC 60601-1-2.
USER MANUAL Page 16 of 92
Disposal of Electronics
2.2 Safety Instructions
2.2.1 General information
Note
Waste generated from the use of the laser device accessories must be
recycled or disposed of in a manner which is safe for both humans and the
environment. Observe the applicable national regulations.
Note
According to the Directive 2002/96 /EC concerning electrical and
electronic used devices, this product is subject to the cited directive and
must be disposed accordingly within Europe.
Before disassembling and disposing of the product, it must be completely
processed according to the section "Disinfection and Sterilization".
Additional information can be obtained from PIOON.
Become thoroughly familiar with the instructions for use. A hazard can
arise from untrained persons who use the device:
Injury to the patient or operator
Damage to the unit
The device may only be used by persons who can properly operate it
due to their training or knowledge and practical experience.
Note
The manufacturer assumes no liability for damage arising from untrained
persons.
Special Care shall be taken to prevent infection from the laser plume
generated by vaporization of viral or bacterial infected tissue. Use of a high
volume suction, personal protective equipment including but not limited to
protective gloves, face mask, face shields, safety and eye wear shall be
used for protection at all times during laser procedures.
USER MANUAL Page 17 of 92
2.2.2 Laser Safety
The S3 medical diode laser system is safe and reliable when used by trained
personnel who take proper care in their operation.
Be aware of adjacent structures and substructures within the oral cavity. Do
not direct the laser energy toward hard surfaces such as a tooth, bone,
fillings or metallic surfaces. Avoid bone contact and never treat
perpendicular to any bone surface.
Only use the laser device in a clinical environment that adheres to
standardize aseptic techniques for oral procedures.
Hazard from electrical power
Electrical shock
Do not open any protective covers.
Do not place any liquids on the device.
In the event of an accidental ingress of a liquid, immediately stop the
procedure, disconnect the power cable and contact PIOON after sales
maintenance for assistance.
Note
All optical components, especially the parts of the laser delivery system,
must be handled with great care and protected from dust and dirt.
The S3 medical diode laser is a Class 4 laser system. Precautions should
be taken to avoid accidental exposure to both directed and reflected laser
beams. Severe eye or skin damage may be caused by diffused reflections
of the laser beam.
The laser beam from most of laser diodes is usually not visible to the
human eye, which can seriously damage retinal tissue.
DO NOT look directly into the laser beam or into the working end of the
optical fiber. Reflected laser beam may also cause retinal damage.
Avoid aiming the laser beam in the direction of reflective surfaces.
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Laser-related fire hazard
WARNING:
A risk of fire and/or explosion exists when the LASER OUTPUT is used in
the presence of flammable materials, solutions or gases, or in an oxygen
enriched environment.
All personnel in the operation area, including the patient, must wear eye
protection. Contact lenses are not viable protection. Eye protection must be
specific to the wavelength in use. All laser safety glasses/goggles have a
specific wavelength range which is indicated on the lens or eyepiece. Care
must be taken to assure that the eye protection is correct to the appropriate
laser radiation. (Protective eyewear is marked with optical density >2 at
650nm and >5 at 980nm wavelength).
POST “LASER IN USE” IN THE OPERATION AREA.
Limit access to the operation area to personnel who are trained in the
principles of laser safety. The laser system has a door interlock that can be
activated if necessary.
DO NOT operate the laser system with any protective panels removed or
when the fiber delivery system is improperly connected.
DO NOT attempt to defeat this system interlock or otherwise access the
enclosures, as it is designed for your protection. High voltage exsits within
the enclosure.
DO NOT attempt repairs of this system. Major service and maintenance
should only be performed by a qualified S3 Service Technician.
CAUTION
Laser fume and/or plume may contain viable tissue particulates.
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Signs in the laser area
Hazard from direct and indirect laser radiation
Surfaces can absorb laser energy. This can cause the surface temperature
to rise and ignite the material.
Never use the S3 in explosive areas or direct the laser beam in the
direction of flammable materials.
Never use flammable substances for anaesthesia during the laser
procedure
Never use the laser device in the presence of anaesthetics that are
flammable when in contact with air, oxygen (O2) and, nitrogen dioxide
(NO2) since these gases can increase the strength and extent of a fire.
Flammable solvents and liquids used for cleaning and disinfecting the
laser device shall be allowed to evaporate / volatize, before working
with the laser.
If flammable materials are necessary during the procedure, ensure they
are kept wet.
Materials such as cotton which is an oxygen saturated material can be
flammable during normal laser use.
Observe all fire hazards caused by flammable gases. Endogenous
gases can explode.
Be particularly careful when using oxygen since oxygen can increase
the strength and extent of a fire.
Maintain fire extinguishing equipment near the procedural room.
The area in which the maximum permissible radiation can be exceeded
from the "laser procedure area" must be delimited and identified by a laser
warning sign.
Entrances shall be posted with the triangular laser warning sign.
The NOHD (Nominal Ocular Hazard Distance) from the laser is 2.5m.
An additional laser warning sign must be provided by the manufacturer with
each laser system. We recommend affixing a sign to the entrance of the
laser procedure room to warn entering persons of the laser in the room.
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2.3 Laser System Safety Features
The S3 system provides the following safety features for both operator and patient:
2.3.1 Laser emission
The laser will only emit when the READY button is activated and when the foot switch
is pressed. The device is in STANDBY mode after the power switch is set to the ON
position. The READY button is activated to enable the foot switch. This is to remind
the operator that the laser is going to emit. The user/ associate (s) and patient shall
wear the protective glasses/ goggles. The laser will emit when the foot switch is
pressed.
2.3.2 Visible and audible lasing signals
Whenever the foot switch is pressed, an audible signal (high pitch beeping) will
sound. A visible LASER FIRING icon will also appear on the screen to indicate that
Serious eye and skin damage
Never look directly into the outlet of the handpiece or glass fibre bundle,
even with protective glasses.
Identify the laser area so that no unauthorized person will enter during
the procedure.
Restrict access to the procedural room to the dentist and assistant.
Cover windows and openings to the procedural room to prevent the
laser from accidentally exiting.
Only direct the active laser to the treatment site of the patient.
No reflecting objects (instruments or holders) may be in the procedure
area.
Make sure that employees know how to turn off the laser in an
emergency.
Use of controls or adjustments or performance of procedures other
than those specified herein may result in hazardous radiation exposure.
All the up, down, left, and right orientations in this manual are based on
the front screen.
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