Pioon H1 User manual

Medical Diode Laser System
USER MANUAL
Model: H1
Wuhan Pioon Technology Co.,Ltd.
Version: V1.0
All rights reserved.
Revision Date: Mar 12, 2019

USER MANUAL Page 2of 69
CONTENTS
1 GENERAL....................................................................................... 4
1.1 User Guide................................................................................................................. 4
1.2 Introduction............................................................................................................... 4
1.3 Intended Uses........................................................................................................... 5
1.4 Contraindications......................................................................................................5
1.5 Purchase of Fibers &Tips.........................................................................................6
2 SAFETY............................................................................................. 8
2.1 Proper Use................................................................................................................. 8
2.2 Safety Instructions................................................................................................. 10
2.3 Laser System Safety Features..............................................................................14
2.4 Clinical Precautions for Laser Safety...................................................................15
3 PRODUCT DESCRIPTION.............................................................17
3.1 System Description................................................................................................ 17
3.2 Product Specifications...........................................................................................20
3.3 Laser Beam Delivery.............................................................................................. 22
3.4 Accessories List......................................................................................................22
4 INSTALLATION.............................................................................. 23
4.1 Installation Instructions......................................................................................... 23
4.2 Unpacking................................................................................................................23
4.3 Installation...............................................................................................................24
4.4 Packing and Transporting the H1
.........................................................................27
4.5 Power Description.................................................................................................. 28
5 FIBER AND HANDPIECE............................................................... 29
5.1 Structure of an Optical Fiber................................................................................. 29
5.2 Stripping the Fiber.................................................................................................. 30
5.3 Cleaving the Fiber................................................................................................... 32
5.4 Instruction for Using the Handpiece.................................................................... 33
5.5 Change Optional Bleaching and Biostimulation Handpiece............................. 36
6 DISINFECTION AND STERILIZATION.........................................37
7 OPERATION PROCEDURE............................................................38

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7.1 Preparations............................................................................................................38
7.2 System boot............................................................................................................ 38
7.3 Operational instructions for customized treatment regimens......................... 39
8 TROUBLESHOOTING.................................................................... 55
8.1 Notation Type..........................................................................................................55
8.2 Notation mode........................................................................................................ 55
8.3 Notation function....................................................................................................56
8.4 Notation system detection.................................................................................... 57
8.5 Fault Diagnosis and Analysis................................................................................57
9 LABELS, SIGNS AND WARNINGS............................................... 59
10 MAINTENANCE............................................................................61
10.1 Daily maintenance................................................................................................61
10.2 Routine Inspection............................................................................................... 62
10.3 The maintenance for long-term storage...........................................................62
10.4 Power calibration..................................................................................................62
10.5 CALIBRATION SCHEDULE...................................................................................63
11 LIMITED WARRANTY................................................................. 64
12 ELECTROMAGNETIC COMPATIBILITY.................................... 65
12.1 Emitted electromagnetic Interference............................................................... 66
12.2 Electromagnetic Immunity..................................................................................66
12.3 Recommended Safe Distance............................................................................ 68
13 CONTACT..................................................................................... 69

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1 GENERAL
1.1 User Guide
Requirement
Read these instructions before the initial startup to prevent misuse and damage.
1.1.1 Symbols
See the section Warning and Informational Signs
Important information for users and technicians
1.1.2 Target group
This document is for dentists and office personnel.
1.2 Introduction
H1 , the DIODE LASER DENTAL SYSTEM, from Wuhan PIOON Technology Co., Ltd.
(PIOON) assembles the latest semiconductor laser technology available for soft
tissue modification and preventative care.
The Medical Diode Laser uses 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. The wavelength produced
by the diode is approximately 450 to 1470 nanometers (nm) . The light is an invisible
non-ionizing thermal radiation that does not create changes in cellular DNA.H1
Medical Diode Laser has continuous mode and pulse mode, and the maximum
output power is 10W. The H1 unit is an air-cooled device.

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For safety, the diode features several ways to stop energy flow if the operator wants
to deactivate the laser. The safety system includes a choice of an emergency
shutdown button, a power switch, and a remote door interlock. Any of these items
can be used to shut down the laser.
Training is recommended and opportunities for such are available through such
outlets of PIOON. Please visit the Academy of Laser Dentistry, dental schools and
many dental continuums. You should also ask your authorized dealer representative
for the names of dentists in your area who have a laser system and who could help
you in a mentoring capacity. There are many applications for using this laser system
and you will be amazed of the results and wonder how you ever practiced dentistry
without H1 .
1.3 Intended Uses
This PIOON product is intended only for use in the field of dentistry. It is Not
recommended to use the product for a purpose for which it was not intended.
The H1 is to be used by physicians and trained medical personnel under medical
supervision. The decision regarding the suitability of the unit and the selection of the
corresponding treatment methods are exclusively the responsibility of the treating
physician.
The H1 Medical system is suitable for the following indications:
Oral soft tissue surgery; periodontal treatment; root canal therapy/treatment,
disinfection; Dentine hypersensitivity (DH).
Symptoms
Pyogenic granuloma; benign hyperplastic tumors; vestibuloplasty; frenectomy;
uncover impacted maxillary canine, implant exposure, periodontitis; endodontic
disinfection; gingival maxillary frenum; root canal therapy/treatment, disinfection;
Dentine hypersensitivity (DH).
1.4 Contraindications
All clinical procedures performed with H1 must be subjected to the same clinical

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judgment and care as with traditional techniques. Patient risk must always be
considered and fully understood before clinical treatment. The practitioner must
completely understand the patient’s medical history prior to the treatment. Exercise
caution for general medical conditions that might contraindicate procedure. Such
conditions may include allergy to local or topical anesthetics, heart disease, lung
disease, bleeding disorders, sleep apnea or an immune system deficiency. Medical
clearance from patient’s physician is advisable when doubt exists regarding the
treatment. There are no known contraindications caused by laser light energy such
as pregnancy and pace makers, etc.
Patients may not be treated who suffer from photodermatoses as well as
photosensitised patients (photoallergies). If the patient presents with malign tumours
and obligate precancerosis, carefully consider the specific Medical for the situation.
1.5 Purchase of Fibers &Tips
The H1 recommends that users purchase and use quartz fiber and TIPS that can
transmit wavelengths from 470nm to 1470nm.This kind of optical fiber is suitable for
the transmission of various wavelength signals and energy from ultraviolet to infrared.
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.
Note
The H1 doesn't provide fiber optics and TIPS, and it requires users to
purchase it by themselves. Before using fiber optics and TIPS, please read
carefully of our company's recommendations for fiber optic material, core
diameter, transmission band, etc., and follow it strictly, otherwise it may
lead to abnormal laser output!
Note
During use of the H1 device, fiber exposure to oral soft tissue can present bi
ological risks. It is advisable to purchase the products that have passed CE/
FDA certification and reduce the biological risks that may occur during the t
reatment.

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It has the advantages of low cost, excellent optical transmission performance and
biocompatibility, high intensity, high reliability and high laser damage threshold,
etc.The recommended fiber optic core diameters can be found in the technical
parameter table in the parameter specification section of this manual. For the fiber
optics and TIPS categories, refer to the H1 component parts of this manual. For
notes on the use of optical fibers, refer to the Chapter 5 of this manual.

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2 SAFETY
2.1 Proper Use
2.1.1 General
The diode laser in the H1 system 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 equipments;
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 must be done annually.
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 operator, person responsible for the device and user must operate their devices

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in accordance with the provisions of the Medical Device Law.
Information on electromagnetic compatibility
Disposal
Note
The product must be cleaned and serviced according to instructions if it is
not to be used for a long period.
Note
Only those accessories may be used that are approved for the device.
Note
Based on EN 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 EN 60601-1-2.
Note
The waste that arises must be recycled or disposed of in a manner safe for
humans and the environment. Observe the applicable national regulations.
Please direct all questions regarding the proper disposal of PIOON products
to the nearest PIOON branch.

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Disposal of Electronics
2.2 Safety Instructions
2.2.1 General information
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.
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 handle it due
to their training or knowledge and practical experience.
Become thoroughly familiar with the instructions for use.
Note
The manufacturer assumes no liability for damage arising from untrained
persons.
Hazard from electrical power
Electrical shock
Do not open any protective covers.
Do not place any liquids on the device.
If liquids penetrate the device, immediately turn it off with the laser
emergency shutdown button, pull the power plug, and notify customer
service.
Note
All optical components, especially the parts of the laser delivery system,
must be handled with great care and protected from dust and dirt.

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2.2.2 Laser Safety
The H1 diode laser system is safe and reliable when used by trained personnels who
take proper care in their operation.
The H1 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 as well as
speckle 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.
DO NOT place any part of the human body in the direct line with the laser
beam. 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(450-1470 nm). All laser safety
glasses/goggles have a specific wavelength range which is indicated on
lens or eyepiece. Care must be taken to assure that the eye protection
wears are correct to the appropriate laser radiation. (Protective eyewear is
marked with optical density at 450 -1470nm 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 exists within
the enclosure.
DO NOT attempt repairs of this system. Major service and maintenance
should only be performed by a qualified H1 Service Technician.

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Laser-related fire hazard
Surfaces can absorb laser energy. This can cause the surface temperature
to rise and ignite the material.
Never use the H1 in explosive areas.
Never use flammable substances for anaesthesia, preparing the
treatment or cleaning and disinfecting the instruments.
If solvents and flammable liquids are used to clean and disinfect, make
sure that they evaporate before working with the laser.
Never use oxidation gases such as dinitrogen oxide (N2O) and oxygen.
Be particularly careful when using oxygen since oxygen can increase
the strength and extent of a fire.
Only store a minimum amount of flammable materials in the treatment
room.
If flammable materials are necessary for treatment, wet them.
Keep articles of clothing away from the treatment unit.
Keep a small fire extinguisher and water in the treatment room.
Note that materials such as cotton can be flammable during normal
laser use when they are saturated with oxygen.
Note than endogenous gases can explode.

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Signs in the laser area
Hazard from direct and indirect laser radiation
During operation, the area in which the maximum permissible radiation can
be exceeded, the "laser area" must be delimited and identified by a laser
warning sign.
At the entrances, the operation of the laser must be announced by warning
lights and the triangular, yellow laser warning sign.
The NOHD (Nominal Ocular Hazard Distance) from the laser is so big that
the entire area in which the laser is used must be considered the laser area.
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 treatment room to warn entering persons of the laser in the room.
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 it during
treatment.
Restrict access to the treatment room to the dentist and assistant.
Cover windows and openings to the treatment room to prevent the
laser from accidentally exiting.
Only direct the active laser to the treatment area.
There may be no metal objects such as clocks or chains in the work
area.
No reflecting objects (instruments or holders) may be in the work 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

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2.3 Laser System Safety Features
The H1 system provides the following safety features for both operator and patient:
2.3.1 Laser firing
The laser is only fired when the READY button is activated and when the footswitch is
stepped. The device is in STANDBY mode after the power switch is set to ON position.
READY button is to be activated to enable the footswitch. This is to remind the
operator that the laser is going to fire or emit, please wear the protective glasses.
Then, the laser will emit when the footswitch is enable or pressed.
2.3.2 Visible and audible lasing signals
Whenever the footswitch is pressed, an audible signal (high pitch buzzing) will sound.
A visible LASER FIRING icon will also appear on the screen to indicate that the laser is
emitting.
2.3.3 Password protection
The device requires a password input of six digits in order to enter the main menu.
2.3.4 Emergency shutdown button
An Emergency Shutdown Button (red round button) serves to turn off the laser of the
device immediately in an emergency. It should only be used in emergencies, that is,
when it is necessary to immediately stop the laser emission. After the emergency, the
button needs to turn clockwise to release out in order to be ready for next emergency.
2.3.5 Remote door interlock
The device is equipped with a Remote Door Interlock. The remote door interlock can
be set by the operator with the entrance door to the operation room. Once the remote
door interlock is installed and activated, the common practise is to have an indication
light on at the outside of the door for warning. Opening the door will shut down the
device. This is to avoid any laser hazard to the personnel who is entering. The
Remote Door Interlock is located and labeled on the left side of the device.

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2.4 Clinical Precautions for Laser Safety
Only practitioners who are thoroughly trained in laser operation procedures, safety
precautions and techniques should use H1 units. A thorough understanding of the
material presented in this manual is highly recommended before any operation.
Before treatment, clinicians need to determine the clinical symptoms of patients,
analysis for appropriate treatment. Take full account of the risk of treatment and get
the patient's permission.
Before and during treatment, clinicians should remind patients of relevant matters
need attention and remind patients to pay attention to prevent safety risks from
distract.
If the patient has special needs, such as people with disabilities, the clinician should
assign at least one trained professional person in this manual to assist him/her
during the operation.
The laser can ignite non-metallic materials. All combustible materials must be
removed from the operation area or should be kept moist during the procedure. The
laser can ignite preparation solutions containing alcohol and/or acetone.
DO NOT leave puddles of preparation solution in the operation area. Vapors may
build up under surgical drapes and create a safety hazard.
Laser treatment may result in inadvertent exposure to adjacent tissues.
Undue exposure can result in damage to the tissue, vessel perforation and
bleeding. The practitioner should always set the laser system for minimal
exposure to the patient. Optimal parameters for laser surgery may be
achieved by starting with the power as low as possible and increase each
parameter as necessary. Power levels affect precision of cut, rate of tissue
removal and thermal damage to adjacent tissues.
Avoid inadvertent laser firing. Turn the laser OFF with the power switch
when not in use for an extended period of time.

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DO NOT place the footswitch in an area where it may be accidentally
pressed. When the laser is not in use, remove the footswitch from the
operator's immediate area.
Avoid tissue splattering on the working end of the delivery fiber, this will
create localized heating, which may cause the fiber tip to char and fail. If
backsplatter occurs, wipe the fiber with alcohol gauze. Allow alcohol to
evaporate before continuing the lasing process. Re-cleave the fiber if
necessary.

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3 PRODUCT DESCRIPTION
3.1 System Description
The H1 is a surgical device designed with compactness, portability, reliability and
user-friendliness. It provides the operator with a versatile tool for surgical on oral soft
tissue. The H1 utilizes a semiconductor diode with invisible infrared radiation as a
laser source and visible red light as indicator light. The laser power is delivered to the
treatment area via a flexible fiber, which has a handpiece. The emission of the laser is
activated by a footswitch.

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21 22
Figure 1 Items
#
ITEM
DESCRIPTION
1
Display
Display all the operation information
2
Holder
Handpiece holder
3
Fiber
Laser energy is transported through the
fiber
4
Indicator
Power(Green)/Notation(red)/Laser(Yellow)
5
Emergency Stop Button
Disables the device In the Event of an
Emergency
6
Fiber Spool
Stores Fiber
7
Handpiece
Treatment Handpiece
8
Handle
For Transporting the Unit
9
Handpiece Port
Connects Handpiece
10
Fiber Port
SMA 905

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11
Lithium ion battery
Back-up power
12
Circuit Breaker
Master ON/OFF Switch
13
DC Power Connector
Connects Power Supply to the Unit
14
Foot switch Connector Port
Connects Wired Foot switch to the Unit
15
Remote Interlock Port
Connects Interlock to the Unit
16
USB Port
Software Update
17
Dental laser handpiece
Soft tissue cutting
18
Foot Switch
The laser signal control
19
Power Line
AC power connection
20
Adapter
AC to DC
21
①Bleaching Handpiece
Handpiece lenses
②Dental Therapy Handpiece
③Transfer Chuck
④Biostimulation Handpiece
22
TIPS
Dental Laser Tips
23
Safety Goggles
Laser protective glasses
24
Other Components
Other components required by customer
A large touch screen displays the working conditions and operation modes of the
device. A menu allows the operator to select or change the system settings for the
appropriate operation procedure. Additional safety features are built in (see Chapter
2).
3.2 Product Specifications
Model
H1
Laser type
GaAlAs
Operation mode
CW/Pulsed
Wavelength(Working)
650±20nm，980±10 nm
Wavelength(Indication)
650±20 nm
Max Output power
10.2±1W
Max Indication power
＜2mW
Uncertainty for output power
≤±10%