Pioon S3 User Manual

Medical diode laser

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Medical Diode Laser

USER MANUAL

Model: S3

Wuhan Pioon Technology Co.,Ltd.

Version: V1.5

Revision Date: JUNE 15, 2021

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Summary of Contents for Pioon S3

Page 2 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.
Page 3: Table Of Contents
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............
Page 4 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................
Page 5: General
1 GENERAL 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...
Page 6 Graphics / symbols Meaning Position Class 4 laser product explanatory & Remote interlock Back side of the main unit & Laser output standard informatioin Emergency Laser Stop Right side of the main unit  Pull the handpiece up Right side of the main unit ...
Page 7 Graphics / symbols Meaning Position The position is on the CE Marking Nameplate Indicates the connection On the connecting wire of for a foot switch the foot switch The position is on the Fragile, be careful outer package The position is on the Keep Dry outer package Transport...
Page 8: Introduction
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.
Page 9: Indication
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.
Page 10: Intended User
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.
Page 11 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.
Page 12 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.
Page 13: Purchase Of Fibers &Tips
Purchase of Fibers &Tips 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...
Page 14: Safety Precaution
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.
Page 15 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.
Page 16: Safety Instructions
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. Safety Instructions 2.2.1 General information Become thoroughly familiar with the instructions for use. A hazard can...
Page 17 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. 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.
Page 18 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.
Page 19 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 ...
Page 20: Laser System Safety Features
All the up, down, left, and right orientations in this manual are based on the front screen. 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.
Page 21 (OD) of 5.0 or greater. Class IV laser radiation is hazardous to the eye from the direct beam and diffuse reflections. Safety goggles not designed to this specification are not suitable for use with S3 medical laser device.
Page 22: Clinical Precautions For Laser Safety
Only clinicians who are thoroughly trained in laser operation procedures, safety precautions and techniques should use S3 units. A thorough understanding of the material presented in this manual is highly recommended before use.
Page 23 If the patient has special needs, such as people with disabilities, the clinician should assign at least one trained professional person to assist him/her during the procedure. The laser can ignite non-metallic materials. All combustible materials must be removed from the procedural area or should be kept moist during the procedure. The laser can ignite preparation solutions containing alcohol and/or acetone.
Page 24: Product Description
System Description The S3 is a surgical device designed with compactness, portability, reliability and user-friendliness. The S3 provides the operator with a versatile tool for surgical uses on oral soft tissue. The S3 utilizes a semiconductor diode with invisible infrared radiation as a laser source and visible red light as indicator light.
Page 25 Figure 1 Items USER MANUAL Page 25 of 92...
Page 26 ITEM DESCRIPTION Display Display all the operation information Holder Hand piece holder Laser energy is transported through the Fiber fiber Indicator Power(Green)/Notation(red)/Laser(Yellow) Disables the device In the Event of an Emergency Stop Button Emergency Fiber Spool Stores Fiber Handpiece Surgical/ Treatment Hand piece Handle For Transporting the Unit Handpiece Port...
Page 27: Product Specifications
Product Specifications Model Galium Aluminum Arsenide (GaAlAs) Laser type diode Operation mode Continuous and Pulse Wavelength(Working) 450±10nm, 650±20nm, 980±10nm Max Output power 3±0.3W, 200±20mW, 7±0.7W Wavelength(Indication) 650±20 nm Max Indication power ＜2mW Uncertainty for output power ≤±10% Magnitudes cumulative ≤±20% measurement uncertainty Expected increase in the measured ≤±10%...
Page 28: Storage And Use Of The Environment
Laser Beam Delivery The laser beam from the S3 is delivered by a flexible quartz fiber or a fiber optic cable. The device accepts a fiber with single core of 200μm to 400μm in diameter and with SMA905 connectors.
Page 29 S3 unit to help maintain the integrity of the fiber. The SMA905 connector of a fiber is inserted into laser output port located on the back side of the housing. There is no need to frequently disconnect the fiber from the unit unless it gets too short or requires a replacement.
Page 30: Installation
Unpack all components carefully and verify the presence of all components on  the packing slip. Notify PIOON immediately if there are any missing items.  Installation The S3 medical laser shall be protected from the intrusion of contaminates and  liquids. USER MANUAL Page 30 of 92...
Page 31 PIOON after sales maintenance for assistance. Place the main unit of S3 on a suitable table, cart, and shelf top, etc. with a  minimum distance of 20 cm to the surroundings. Attach all items in place in the following steps.
Page 32 Figure 2 The connecting positions of power adapter and remote interlock. E. Carefully take the fiber roller out of package and check for damage. The fiber cable is about 3 meters long. DO NOT bend or apply physical pressure to the fiber with radius less than 50mm or to an angle less than 90 degrees. F.
Page 33 Note To protect the optical components in the device, the SMA905 socket in the unit must always be closed (with either a fiber cable or a protective cap). Note Only use fibers with clean fiber ends.  Insert the SMA connector of the fiber completely into the SMA socket and screw the union nut tight.
Page 34: Packing And Transporting
M. Set up of the S3 laser device shall be complete before putting the laser into use. N. National Directives regarding electrical installations shall be observed.
Page 35: Power Description
S3 has two power supply modes: external power supply adapter and internal lithium battery. The S3 needs to be at least 20 cm away from the wall and other objects to ensure smooth ventilation and facilitate power switch operation. Press the power switch to the ON position to start the device.
Page 36: Software Installation And Upgrade
Software installation and upgrade Under the guidance of the manufacturer or supplier, the professional equipment operators receive the software installation package issued by Wuhan PIOON company.The software installation package is included in the usb drive provided by Wuhan PIOON company.
Page 37: Fiber And Hand Piece
5 FIBER AND HAND PIECE 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 recommended fiber optic material...
Page 38 Never twist, bend, fold, jam or pull on the optical fiber of the single use tip. These actions will cause the tip to break. Immediately stop the laser emission in the event of a broken tip and change to an intact tip. Damaged tips may become hot. Avoid touching any tissue with the metal cannula tip.
Page 39: Assembly Of The Hand Piece
The use of optical fiber tips from other manufacturers may have other physical properties such as load carrying capacity and transmission behavior. PIOON assumes no liability for any damage caused by use of other manufacturers single use tips. Use only PIOON single use optical fiber tips.
Page 40: Disconnecting The Fiber And Tip
The assembly of the hand piece may be completed through the following steps: A. Release the front and mid-ends respectively (Figure 5); B. Put the fiber into the hand piece, adapter and tip; C. Tighten the mid-end adapter; D. Approximately 3–4 in (~7–10 cm) of fiber should protrude; E.
Page 41: Assembly Of Disposable Fiber Tips On Optional Fiber Hand Piece
Figure 6 Assembly of Disposable Fiber Tips on Optional Fiber Hand Piece A. Remove the cap of the Fibre tip; B. Remove the protection cap of the hand piece; C. Insert the Fibre tip to the hand piece; D. Feed the tip and hand piece through the cap with hole; E.
Page 42 Figure7 Assembly of the Disposable Fiber Tips Verify the aiming beam is illuminating evenly by projecting the beam vertically on a non-reflective working surface or a piece of white paper. The aiming beam should project a circular light pattern. If the beam does not protect a circular pattern as portrayed above or the beam pattern does not illuminate evenly, the single use tip may be defective.Do not use damaged or defective single use tips.
Page 43: Post Procedure
Post Procedure Wearing medical surgical personal protective equipment gloves,  Disconnect the single use tip from the hand piece Tips must be disposed in a biohazard medical waste container.  Immediately upon disassembling the single use tip after the procedure, ensure the protective optical fiber cap is placed over the fiber port to prevent ingress of dust or other debris into the optical system.
Page 44 Cladding Cladding is the material on the outside of the quartz/silica fiber core that is used to block the lateral escape of laser energy as it traverses the fiber. During stripping, you may “nick” the cladding and you will likely see the red aiming beam light as it escape the site of the damage.
Page 45: Stripping The Fiber
Stripping the Fiber The jacket of a clean and disinfected fiber can be removed easily with your fingers. When the laser emits from the fiber tip, it is easy to retain debris from tissue splattering and the fiber tip becomes blackened and deteriorated. When the blackened tip extends 3-4 mm up the fiber shaft, it is time to cleave the fiber and prepare a new tip for the next procedure.
Page 46: Cleaving The Fiber
Figure 10 Stripping procedure. Figure 11 Remove 10 to 20mm of the jacket. Cleaving the Fiber As the tip deteriorates, it is more likely to fracture and could fall into the sulcus or a deep periodontal pocket. To avoid this problem, it is prudent to periodically “cleave” the discolored tip.
Page 47 enough pressure to ”score” the fiber. See Figure12 . C. With the thumb and index finger of each hand holding the fiber at a spot approximately 8-10mm on either side of the cleave mark, break fiber against cleave. See Figure 13. D.
Page 48 Figure 14 Checking the cleave quality by observing the pattern of the aiming beam. USER MANUAL Page 48 of 92...
Page 49: Disinfection
6 DISINFECTION The S3 medical diode laser is not supplied in sterilized condition. It should be disinfected before use. The following disinfecting procedures are recommended for the device and the attachments to the device. Note Wear appropriate Personal Protective Equipment (PPE) when performing cleaning and disinfecting procedures.
Page 50 each use. Reattach the protective cap to the optical system immediately after removing the tip and prior to cleaning procedures. Before disinfection, the hand piece must be cleaned and disassembled. Disinfection for Hand piece recommended autoclave cycle for the Hand piece is: Temperature: (132°C) Pressure:...
Page 51 Observe the instructions for use and all specifications provided by the manufacturers of the cleaning products and disinfectants. Recommended cleaning and disinfection solutions consist of: A. BIREX™ B. CIDEX®Steam Store all disinfected and clean components in a clean area so that they are protected against contamination.
Page 52: Operation Procedure
7 OPERATION PROCEDURE The S3 medical diode laser is not supplied in sterilized condition. The main unit must be disinfected and applicable components disinfected or sterilized before use. Reference Disinfection and Maintenance sections of this manual. Note There are two output modes: continuous and pulse in the S3 medical diode laser.
Page 53: Use Instructions For Customized Management Regimens
2）System starts running; 3）Enter in the home page. Use instructions for customized management regimens 1）Turn on the device and enter the login page, input the Passcode. Note: Login password should be 4 digits. Figure1 PIN Code Input Interface 2）Enter the right code and get in the Home page(Figure 2) Figure 2 Homepage Memu 3) Click on "Presets"...
Page 54 Figure 3: Official preset classification 3-1) Click on the official preset category and enter the preset name list under the category (Figure 3-1) Figure 3-1: preset name 3-2) Click on the preset name to enter the official preset page. (3-2-1) In Quick mode(default), The user can only adjust the power value within the allowed range (Figure 3-2-1) USER MANUAL Page 54 of 92...
Page 55 Figure 3-2-1: Quick mode parameter setting page 3-2-2) In Expert mode, the user can adjust all preset parameters as their need, and click the undo button to restore the initial values of the preset (Figure 3-2-2) Figure 3-2-2: Expert mode parameter setting page 3-2-3) After the user emitted more than 6 times in a official preset, a quick presets list will be automatically generated (Figure 3-2-3)
Page 56 Figure 3-2-3: Quick presets list 3-2-4) The quick presets list will pop up automatically when you enter the home page, and you can directly enter the Ready state by selecting the preset (Figure 3-2-4) Figure 3-2-4: Quick preset emitting page 3-2-5) After the emission in official preset, a treatment evaluation prompt will pop up, which can be evaluated according to the treatment results, and this pop-up window can be selected to close (Figure 3-2-5)
Page 57 Figure 3-2-5: Treatment evaluation page 3-2-6) Official presets treatment page, click to view treatment assistance and guidance video. (Figure 3-2-6) Figure 3-2-6: Treatment assistance page 4) Click customize to enter the customize interface. ①When entering the customize interface for the first time, a tutorial for beginners will guide the user to be familiar with the buttons and basic functions of customize.
Page 58 Figure 4-1: Customize tutorial interface-Select CW/Pulse mode （4-2）Next, the Customize tutorial interface prompts to adjust the wavelength and power; (Figure 4-2) Figure 4-2: Customize guidance interface - Adjust the wavelength and power 4-3) Next, the Customize tutorial interface prompts to select the wavelength and set power.
Page 59 Figure 4-3: Custom guide interface - Select wavelength and set power 4-4) Customize tutorial interface - set countdown time; (Figure 4-4-1) 图 4-4-1: Customize tutorial interface - Set countdown time 4-5) Set the countdown pop-up box at the range of 0-3600s, and if you set the countdown, the laser emitting will stop after the countdown (Figure 4-4-2) USER MANUAL Page 59 of 92...
Page 60 Figure 4-4-2: Set the countdown time 4-5-1) Customize tutorial interface - Standby, click Standby to switch to Ready State (Figure 4-5-1) Figure 4-5-1: Customize tutorial interface-Standby 4-5-2) Tap Standby to switch to Ready state (Figure 4-5-2) USER MANUAL Page 60 of 92...
Page 61 Figure 4-5-2: Ready state 4-5-3) In ready state, press the handle or foot switch to emit the laser, the interface will switch to EMTTING state, at this time you can not modify any parameters. If you need to modify the parameters, please return to the Standby or Ready state; (Figure 4-5-3) Figure 4-5-3: Emitting state 4-6) In customize interface, the user can customize the parameters including the...
Page 62 Figure 4-6: Customize Preset Parameters page 4-6-1) In pulse mode, the pulse width can be set in the range of 1-999ms or 25-999us; Figure 4-6-1: Setting the width of pulse interval Buttons/Icons Meaning Positive pulse width: Settable Parameter. Negative pulse width: Settable Parameter. Indicator switch: when the indicator switch is red , the indicator is on, and when it is white...
Page 63 Countdown function: when the initial value of timer is 00:00, the laser emitting will be counted down; when the timer is set, the light will be counted down, and the laser emitting will stop automatically when the time is over. Laser emitting indicator button: the default state of power on the standby mode When the treatment plan is set up click this button to enter the...
Page 64 (Figure 5) Note: When saving a solution, users can choose the preset name of the existing solution category, or click NEW to create a new solution category and name, which will be displayed in the list of favorite presets after successful saving. Figure 5: Presets saving interface 6 ）...
Page 65 Figure 6-1: Delete favorite presets pop-up window 7）Click on Q-start to go to the Quick laser emitting interface (Figure 7). Note: ①The user can quickly select the mode, power, pulse width. Then click on the standby and step on the foot switch to emit the laser. ②In ready state, the wavelength can be switched directly.
Page 66 Figure 8: Activity information page 9) Users can click on the service information icon to view the content of the contact information (Figure 9). Figure 9: Contact interface 10) Users can click on the Bluetooth icon to search for a Bluetooth foot switch to connect (Figure 10).
Page 67 Figure 10: Bluetooth foot switch connection page 11) Click the video button to enter the video playback page (Figure 11) ① Click on "local video" to view online videos. ② Tap "ALL" to filter the videos under different preset categories. ③...
Page 68 Figure 11: Video List 12) Click the Settings button to access the settings interface (Figure 12) Figure 12: Settings page (12-1) Click the WiFi button to search for a WiFi connection, (Figure 12-1). ① After a successful WiFi connection, the device can automatically connect to the network each time it is turned on.
Page 69 Figure 14-1: WiFi List 14-2) Click user to create/edit/delete user information; ① Click "QUICK MODE" or "EXPORT MODE" to select the user type as Quick mode or Expert mode. ② Click "Personalized Switch" to select whether to turn on the function of Quick Presets List;...
Page 70 Figure 14-3: Indication light intensity setting page 14-4) Click Sound Settings to adjust the device sound and buzzer sound volume (Figure 14-4) Figure 14-4: Sound and buzzer size setting page 14-5) Click the brightness adjustment button to adjust the screen brightness (Figure 14-5).
Page 71 Figure 14-5: Brightness setting page 14-6) Click on the time setting, and after networking, select the time zone to update the current time (Figure 14-6). 14-6: Time zone selection page 14-7) Click on the Language button to choose to switch the language (Figure 14-7).
Page 72 Figure 14-7: Language selection page (14-8) Click Device Information to view the device information of the device (Figure 14-8) Note: When a small red dot appears in the column of presets version and software version, it means there is a new version available for update, and you can choose to upgrade by clicking the small red dot after networking.
Page 73: Troubleshooting
8 TROUBLESHOOTING Reminding Type The system provides five reminding prompts, namely:  High temperature reminding  Low temperature reminding  Remote interlock reminding  Foot switch reminding  Fiber reminding  Emergency reminding All of the above remindings are technical remindings. When the reminding occurs, the user to do the appropriate treatment according to the priority of the reminding to prevent personnel and device damage.
Page 74 Type of safety reminding Reminding condition High temperature reminding Low temperature reminding Remote interlock reminding Foot switch reminding Fiber reminding Emergency reminding 8.2.3 Indicating light reminding USER MANUAL Page 74 of 92...
Page 75: Reminding Function
When the reminding prompt appears, the red light of the reminding indicator will be on. When the reminding is released, the red light turns off. Reminding function The Medical Diode Laser monitors the operating status of the system in real time. through Sounds, indicators, and graphical warning signs alert user happened unusual events and interrupting the laser laser outputting.
Page 76: Reminding System Detection
Reminding system detection The user can determine whether the reminding system is normal by self-test: For example, if the user unplug the remote interlock, the system will sound, reminding indicator, graphical warning signs and other reminding status. After verifying the reminding system is normal, please restore the remote interlock.
Page 77 1. Clean the glass lens with a paper 1. The glass lens of towel; Laser power handpiece is with dust or other 2. Calibrate the laser power according to attenuation dirt; the instructions 2. Laser attenuation; 3. Contact the company for after-sales maintenance;...
Page 78: Maintenance
9 MAINTENANCE WARNING This product is a Class 4 laser product. During use and maintenance, do not look into the laser or direct beam to avoid irreversible damage to the eyes. It is strongly recommended that users carefully read and thoroughly understand the instructions to avoid injury and damage to the device that caused by the possible harmful laser radiation.
Page 79: Routine Inspection
Do not disassemble the device to avoid injury and damage to the device that caused by the possible harmful laser radiation. 7) PIOON recommends carrying out a routine inspection and maintenance and power calibration every year under the guidance and operation of our authorized company personnel or designated dealers to avoid possible damage to the device and harmful laser radiation on personnel.
Page 80: Cleaning Of The Main Unit
Appropriate steps shall be taken by the operator between procedures of the laser device and components to ensure the distal parts coming into direct or indirect contact with the patient such as the applicator treating head/hand piece receive a thorough cleaning process. Thorough manual cleaning shall be completed immediately after procedures by the operator for all reusable components to assure all surfaces are completely free of any organic or inorganic material to prevent patient to patient transmission of...
Page 81: The Maintenance For Long-Term Storage
PIOON or a designated dealer for power calibration. Calibrations shall be carried out under the direction of authorized personnel of PIOON or a designated dealer to avoid possible injury or damage to the device from harmful laser radiation.
Page 82: Electromagnetic Compatibility
OPERATOR should turn off the device and wait for the elimination of electromagnetic interference before treatment. The purchaser or user of the S3 medical diode laser instrument should use the S3 medical diode laser instrument in the electromagnetic environment specified in this section to ensure the operating functions of the device.
Page 83: Components Information
Note Portable and mobile radio frequency communication equipment may affect the normal use of S3 medical diode laser device.Hospitals except for near active HF SURGICAL and the RF shielded room of an ME SYSTEM for magnetic resonance imaging,where the intensity of EM DISTURBANCES is high.
Page 84: Rf Transmitting
Voltage Fluctuations Flicker Emissions EN 61000-3-3 IMMUNITY TEST LEVELS 10.3 IMMUNITY TEST LEVELS for BASIC SAFETY and ESSENTIAL PERFORMANCE of S3 shall be according to the professional healthcare facility environment,baser on the IEC 60601-1-2:2014. USER MANUAL Page 84 of 92...
Page 85 10.3.1 ENCLOSURE PORT IMMUNITY TEST LEVELS Phenomenon Basic EMC standard or test method professional healthcare facility environment ELECTROSTAIC ±8 kV contact DISCHARGE IEC 61000-4-2 ±2 kV, ±4 kV, ±8 kV, ±15 kV air (ESD) 3 V/m Radiated RF EM IEC 61000-4-3 80 MHz - 2.7 GHz fields 80 % AM at 1 kHz...
Page 86 10.3.2 Input a.c. power port IMMUNITY TEST LEVELS Phenomenon Basic EMC standard professional healthcare facility environment Electrical fast transients/ ±2 kV IEC 61000-4-4 bursts 100 kHz repetition frequency Surges Line-to-line IEC 61000-4-5 ±0.5 kV,±1 kV Surges Line-to-ground IEC 61000-4-5 ±0.5 kV,±1 kV,±2kV 0.15 MHz - 80 MHz Conducted disturbances...
Page 87 10.3.3 Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment USER MANUAL Page 87 of 92...
Page 88 WARNING Keep away from strong radiation sources and electromagnetic interference environment. External RFI and electromagnetic interference will affect the normal operation! Such as cardiac pacemakers and other device sensitive to electromagnetic environment, please try to avoid using together. USER MANUAL Page 88 of 92...
Page 89: Waste Disposal
Disposal is an option when lasers are of no value and only after the laser is rendered inoperable. Contact PIOON or an authorized Service Center. USER MANUAL Page 89 of 92...
Page 90: Service
12 SERVICE 12.1 Quality Commitment PIOON guarantees the factory technical parameters of S3 is in line with the product standard requirements of the medical device, is regulatory approved, and provides a lifetime diode warranty and a 3-year manufacturer warranty. 1. To provide laser training and clinical guidance 2.
Page 91 PIOON sole liability under contract or warranty or otherwise for the product. WARNING Do not modify this equipment without authorization of the manufacturer. USER MANUAL Page 91 of 92...
Page 92: Contact
13 CONTACT If you have any difficulties in the use of your surgical laser, or have any questions and suggestions, please visit www.PIOON.com, call or write to us. The Manufacturer: Wuhan Pioon Technology Co.,Ltd., Address: 7th Floor, A21 of Sino Pharm Building, Biolake Innovation Park, No.666...