SYMBYX BIOME ProSeries Instruction Manual
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SYMBYX BIOME ProSeries Instruction Manual

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  • Page 1 Instruction Manual ProSeries...

  • Page 2: Table Of Contents

    INSTRUCTION MANUAL FOR PROSERIES MEDICAL LASER Contents Table of Contents 1. GENERAL INFORMATION Product Description 1.1.1 Accessories Separate Power Supply Source (Mains Supply Transformer) Essential Performance And Basic Safety Temperature Range For Use Indoors User Restrictions General Caution And Warning Statements Licensing 2.
  • Page 3 INSTRUCTION MANUAL FOR PROSERIES MEDICAL LASER 4. TREATMENT CONTROLS Overview Chart of The Treatment Controls Treatment Application 5. TREATMENT ADJUSTMENTS Skin Phototypes, Hair Colours Skin Types, Body Modifications, Tattoo Colours Body Constitution 6. MEDICAL RECORDINGS 7. DEVICE APPLICATION SPECIFICATION Description 7.1.1 Expected Service Life Medical Purpose / Intended Use Patients...
  • Page 4 INSTRUCTION MANUAL FOR PROSERIES MEDICAL LASER 7.12 Contraindications 7.13 Side Effects 7.14 Patient Reaction 7.15 Patient Population 7.16 Intended Operator 7.17 Operator Responsibilities 7.18 Responsible Organization 7.19 Patient Position 7.20 Training 8. GENERAL BATTERY SAFETY INFORMATION Battery Safety Warnings and Precautions Recycling of Batteries Replacement of Battery Transport and Packaging of The Device for Change of Battery...
  • Page 5 INSTRUCTION MANUAL FOR PROSERIES MEDICAL LASER 10. GENERAL ELECTRICAL AND MECHANICAL SAFETY 10.1 Cleaning / Disinfection Procedures 10.2 Visual Inspections 10.3 Information for Service Technicians 11. DESCRIPTION OF CONTROLS, MESSAGES AND INDICATORS 11.1 LCD-display 11.2 Treatment control 11.3 Treatment control 11.4 Treatment control 11.5 Treatment control 11.6 Joule Set control button...
  • Page 6 INSTRUCTION MANUAL FOR PROSERIES MEDICAL LASER 13. TECHNICAL SPECIFICATIONS (LASER) 13.1 Laser Diode for Laser Probe 904 nm 13.2 Laser Diode for Laser Probe 635 nm 100mW 13.3 Laser Diode for Laser Probe 635 nm 400 mW 13.4 Laser Diode for Laser Probe 808 nm 14.

  • Page 7: General Information

    1. GENERAL INFORMATION This instruction manual applies to the ProSeries Medical Laser by SYMBYX. This laser device is manufactured by Spectro Analytic Irradia AB of Sweden and is the result of a product collaboration between the two companies. (Note: Irradia also manufacture an identical product called the MID 2.5 Laser).

  • Page 8: Accessories

    INSTRUCTION MANUAL FOR PROSERIES MEDICAL LASER SUPPLY through the Lithium-Ion battery charger, and INTERNALLY POWERED when not. The MAXIMUM MAINS VOLTAGE is 250 V. The ENCLOSURE of the MAINS SUPPLY TRANSFORMER and the HAND-HELD device are classified as IP20. The equipment is classified for CONTINUOUS OPERATION in NORMAL USE.

  • Page 9: User Restrictions

    INSTRUCTION MANUAL FOR PROSERIES MEDICAL LASER User Restrictions Various safety features have been included and built into the design of the device. Failure to follow the instructions for the use, transport and storage of the device can lead to battery fluid leakage, heat generation, fire or battery explosion. Failure to follow the security precautions and instructions for use may lead to a potentially dangerous exposure of the eyes (by intra beam viewing at close range), or thermal skin injury (by applying high output power on dark pigmented skin).

  • Page 10: Device Description And Use

    INSTRUCTION MANUAL FOR PROSERIES MEDICAL LASER 2. DEVICE DESCRIPTION AND USE This device is a transportable, battery-operated medical laser product, with which the operator administers non-invasive transient class 3B infrared or visible laser light to reduce pain and inflammation, as well as to promote tissue repair and recovery. This device is intended to be used as a supplementary treatment modality intended to be operated by a variety of practitioners, e.g., doctors, nurses, veterinaries, dentists, physiotherapists, dermatologists, chiropractors, and massage therapists.

  • Page 11: Operation Description Of Laser Treatment (General)

    INSTRUCTION MANUAL FOR PROSERIES MEDICAL LASER This device is designed to enable the operator to administer efficient and safe laser treatments with ease. Generally recommended parameters, which are considered optimal for each treatment point on the basis of studies and clinical practice, have been built into the design and the controls of the device.

  • Page 12: Device Overview Base Unit / Table-Top Unit

    INSTRUCTION MANUAL FOR PROSERIES MEDICAL LASER Device Overview Base Unit / Table-Top Unit...

  • Page 13: Device Overview Hand-Held Units (Laser Probe)

    INSTRUCTION MANUAL FOR PROSERIES MEDICAL LASER Device Overview Hand-Held Units (Laser Probe)

  • Page 14: Primary Operating Functions

    INSTRUCTION MANUAL FOR PROSERIES MEDICAL LASER 3. PRIMARY OPERATING FUNCTIONS Use the key switch to put the device in operational mode (unlocking the device for use). The device enters a STAND-BY state. A yellow Light Emitting Diode (LED) is lit when the key switch is turned, indicating STAND-BY. Press and release the push button to turn on the device (activate the device).

  • Page 15: Charging Of The Battery

    INSTRUCTION MANUAL FOR PROSERIES MEDICAL LASER Remove the key. Clean the device with disinfectants (see 10.1). w) Place the device in a safe and dry location (storing). Make sure that the Li-Ion charger is unplugged from the mains supply (wall socket or similar). Charging of The Battery The device is intended to be used within the temperature range of 0 –...
  • Page 16 INSTRUCTION MANUAL FOR PROSERIES MEDICAL LASER If the Light Emitting Diode on the charger is not lit – neither green nor orange – then the charger is not functioning as intended. Contact service for support. Note: The device can be used without a connection to the charger. When used without connection to charger, the battery time before the need to recharge will vary depending on which hand-held laser devices (laser probes) are used.

  • Page 17: Treatment Controls

    INSTRUCTION MANUAL FOR PROSERIES MEDICAL LASER 4. TREATMENT CONTROLS The treatment controls are indicated by the following symbols: When a control button is pressed, the device sets automatically the parameters required for delivering a generally optimal dose per application point onto and around a condition. When pressed, the Light Emitting Diode (LED) next to the control button is lit and the output power (in mW) and dose (in Joules) and time set signal per application point is shown on the LCD display.
  • Page 18 INSTRUCTION MANUAL FOR PROSERIES MEDICAL LASER Overview per laser diode Treatment control button Adjustment/setting Laser type/output power Signal 904 nm 60 mW 10 seconds / 0.6 J 808 nm 80 mW 30 seconds / 2.4 J Lowest output power 660 nm 25 mW 30 seconds / 0.75 J 635 nm 25 mW 30 seconds / 0.75 J...

  • Page 19: Treatment Application

    INSTRUCTION MANUAL FOR PROSERIES MEDICAL LASER 904 nm 60 mW 120 seconds / 7.2 J 808 nm 500 mW (808-1) 30 seconds / 15.0 J 808 nm 400 mW (808-3) 30 seconds / 12.0 J Highest output power 660 nm 100 mW 30 seconds / 3.0 J Highest dose/time per point 635 nm 100 mW...
  • Page 20 INSTRUCTION MANUAL FOR PROSERIES MEDICAL LASER Broken or sensitive 904 nm 0.6 J to 7.2 J 10 s to 2 min skin, wounds Broken or sensitive 808 nm 80 to 150 mW 10 s to 2 min skin, wounds Non-contact, at air distance of 2 to 5 cm, Broken or sensitive 660 nm / 635 nm...

  • Page 21: Treatment Adjustments

    INSTRUCTION MANUAL FOR PROSERIES MEDICAL LASER 5. TREATMENT ADJUSTMENTS Skin Phototypes, Hair Colours Different skin pigmentation is due to the amount of melanin pigment in the skin and is assessed on a scale from I-VI. The skin phototype is determined by complexion (white, brown or black skin) and the result of exposure to ultraviolet radiation (tanning). In connection with laser treatments, brown and black skin and hair are more easily burned due to the absorption of light in melanin.

  • Page 22: Body Constitution

    INSTRUCTION MANUAL FOR PROSERIES MEDICAL LASER Light brown skin, light May cause an uncomfortable Use the lower treatment settings or output powers if it brown hair sting if higher output powers is uncomfortable for the patient. Alternatively, perform are used on darker spots. treatment in a non-contact mode.
  • Page 23 INSTRUCTION MANUAL FOR PROSERIES MEDICAL LASER High amount of body fat or Large people, body builders Increase the power and dose by selecting another treatment extreme muscle mass control for the treatment than normal. And/or double the treatment time per application point. Use contact pressure when performing treatment application.

  • Page 24: Medical Recordings

    INSTRUCTION MANUAL FOR PROSERIES MEDICAL LASER 6. MEDICAL RECORDING It is recommended that the medical record contains the following information: • Diagnose, description of condition. • Used treatment control (i.e., output power(s) and Joules per point). • Application area (i.e., where the laser radiation has been applied). •...

  • Page 25: Device Application Specification

    INSTRUCTION MANUAL FOR PROSERIES MEDICAL LASER 7. DEVICE APPLICATION SPECIFICATION Description The device is a transportable, hand-held and battery powered medical laser with which the operator administers non-invasive class 3B laser infrared or visible laser radiation to a patient. 7.1.1 Expected Service Life Three years, assuming high usage levels.

  • Page 26: Application

    INSTRUCTION MANUAL FOR PROSERIES MEDICAL LASER Application Contact application on intact skin and skin around orifices. Non-contact application on broken or sensitive skin, as well as on wounds and natural or artificial orifices. Caution: Never to be applied on eyes or used for treatments through the lens of the eye, including intra-beam viewing. Environment Indoors, 10-90% atmospheric humidity at temperatures ranging from 0 to 28°C and at air pressure of 700-1060 hPa.

  • Page 27: Number Of Treatments / Sessions Per Patient

    INSTRUCTION MANUAL FOR PROSERIES MEDICAL LASER 7.10 Number of Treatments / Sessions Per Patient 1-20 treatments; normally 2-4 treatments on acute conditions, while chronic generally require more treatments 5-20. 7.11 Treatment Session Interval The first cycle lasts for three weeks, followed by a pause of two to three weeks before the next three-week cycle starts. 7.12 Contraindications Treatment of the eye through the lens;...

  • Page 28: Patient Population

    INSTRUCTION MANUAL FOR PROSERIES MEDICAL LASER 7.15 Patient Population Age: > 8 years to geriatric. Weight: Not relevant. Height: Not relevant. Gender: Not relevant. Pregnancy: Not recommended. Avoid treatment of the abdominal region. There is, however, no evidence of any known risks for either the mother or foetus. Nationality: Not relevant.

  • Page 29: Intended Operator

    INSTRUCTION MANUAL FOR PROSERIES MEDICAL LASER Medications, drugs, anaesthetics: Caution should be taken when treating patients on drugs, medications or anaesthetics reducing skin sensitivity or ability to respond to pain. See Note 1. Cosmetic products: Skin care and cosmetic products, oils, creams and lotions that have been placed on the skin can reduce the effect of the treatment by the absorption of light, cause damage to electrical components, and render the hygienic handling and cleaning of the device more difficult.

  • Page 30: Operator Responsibilities

    INSTRUCTION MANUAL FOR PROSERIES MEDICAL LASER 7.17 Operator Responsibilities It is recommended that every device is under the care of only one person/operator who is well acquainted with its use and functions. The responsible person for the device should; • read and understand the accompanying documents. •...

  • Page 31: Patient Position

    INSTRUCTION MANUAL FOR PROSERIES MEDICAL LASER • Well acquainted with the device. • Familiar with the instructions for use and the accompanying documents. • Medically trained. • Trained in laser safety. In addition, the responsibilities incorporate; • Ensuring the supply of proper and correct eye protection wear. •...

  • Page 32: Training

    INSTRUCTION MANUAL FOR PROSERIES MEDICAL LASER • Irradiation in the region of the gonads; the application of therapeutic laser in the region of the gonads cannot be considered as contraindicated, but it is recommended that the procedure is performed by specialists with sufficient experience. •...

  • Page 33: General Battery Safety Information

    INSTRUCTION MANUAL FOR PROSERIES MEDICAL LASER 8. GENERAL BATTERY SAFETY INFORMATION This product contains a rechargeable lithium-ion battery. The lithium-ion battery pack is placed inside the device and only accessible by use of a tool. The battery inside the device shall only be replaced by service personnel authorized by or trained by the manufacturer.

  • Page 34: Battery Safety

    INSTRUCTION MANUAL FOR PROSERIES MEDICAL LASER Battery Safety Removal of the battery should only be performed by trained service personnel. The operator must not use the device if deformed or damaged, dropped in water, producing excessive heat, or smells strangely. In these cases, the operator should contact the supplier or the manufacturer for technical service or replacement of parts.

  • Page 35: Recycling Of Batteries

    INSTRUCTION MANUAL FOR PROSERIES MEDICAL LASER • Do not use the battery for any other purpose than for which the product is intended. Do not connect it to any other electrical devices. • Do not charge or use the lithium –ion batteries with the + (positive) and – (negative) terminals reversed. Charging the batteries with the terminals reversed may drain rather than charge the battery, as well as cause abnormal chemical reactions inside the battery, abnormal current flow during discharge, battery fluid leakage, heat generation, explosion or fire.

  • Page 36: Replacement Of Battery

    INSTRUCTION MANUAL FOR PROSERIES MEDICAL LASER Replacement of Battery Contact the supplier SYMBYX Pty Ltd when need of replacement of battery arises, or if a screw is missing on the battery cover. Do not use device unless both screws are in place.

  • Page 37: Laser Safety

    INSTRUCTION MANUAL FOR PROSERIES MEDICAL LASER 9. LASER SAFETY General Laser Safety Information These instructions for use are intended to minimize hazardous situations and the risk of harm due to laser radiation of Class 3B. They include such things as: •...

  • Page 38: General Risks With Class 3B Lasers According To Iec 60825-1

    INSTRUCTION MANUAL FOR PROSERIES MEDICAL LASER The equipment should be protected against unauthorized use, for example by removing the key from the key switch to ensure that the equipment is permanently turned off. The laser apertures are indicated by a “LASER APERTURE” label placed in close proximity to the apertures.
  • Page 39 INSTRUCTION MANUAL FOR PROSERIES MEDICAL LASER that is much lower than intended or what has been specified may result in poor or ineffective treatments. If the output power is much higher (+50%), the patient may experience discomfort depending on the treatment setting being used. In addition, the NOHD at maximum output power is increased.

  • Page 40: The Power Meter / Power Tester

    INSTRUCTION MANUAL FOR PROSERIES MEDICAL LASER “Caution: Use of controls or adjustments or performances of procedures other than those specified herein may result in hazardous situations.” The intent of the warning is to inform the operator that BASIC SAFETY may be compromised by not using the device in its normal condition and in accordance with normal practice and intended use.

  • Page 41: General Electrical And Mechanical Safety

    INSTRUCTION MANUAL FOR PROSERIES MEDICAL LASER 10. GENERAL ELECTRICAL AND MECHANICAL SAFETY 10.1 Cleaning / Disinfection Procedures The device is not intended to be sterilized. The equipment is intended for direct physical contact with the patient on clean and dry skin (normal skin conditions).
  • Page 42 INSTRUCTION MANUAL FOR PROSERIES MEDICAL LASER Inspection of the housing Damaged mechanical parts or a deformed Do not use the device. The battery may (overview of the device) shape, such as dents, may indicate that the be damaged. Contact the supplier or device is no longer functioning normally.

  • Page 43: Information For Service Technicians

    INSTRUCTION MANUAL FOR PROSERIES MEDICAL LASER Green LED is lit when the push If not lit; failure of switch or LED. Contact the supplier or manufacturer for button is pressed ON technical service and replacement of part. (Ready-state) Laser aperture LEDs are lit If not lit;...

  • Page 44: Description Of Controls, Messages And Indicators

    INSTRUCTION MANUAL FOR PROSERIES MEDICAL LASER 11. DESCRIPTION OF CONTROLS, MESSAGES AND INDICATORS 11.1 LCD-display The LCD display shows the treatment time and the number of joules applied on a condition. [Time] 00:00 [Joules] 00.0 J [Frequency] 250 Hz (700Hz for 904 nm lasers) [Laser type] _ _nm _ _mW The treatment time is displayed in hours, minutes and seconds.

  • Page 45: Treatment Control

    INSTRUCTION MANUAL FOR PROSERIES MEDICAL LASER 11.5 Treatment control Control button for highest output power or highest dose/time per treatment point. “Deep” For more information see table in section 4.1 When the control button is pressed down, the information of the pre-set values for the connected laser are shown on the LCD display until the control is released.

  • Page 46: Battery Status Indicator

    INSTRUCTION MANUAL FOR PROSERIES MEDICAL LASER 11.9 Battery status This LED is lit when the battery is getting low and soon needs to be recharged. The remaining battery indicator time depends on the output power (mW) used. A low output power increases the time before recharging is necessary.

  • Page 47: Technical Specifications (General)

    INSTRUCTION MANUAL FOR PROSERIES MEDICAL LASER 12. TECHNICAL SPECIFICATIONS (GENERAL) Product Medical electrical equipment Type Therapeutic laser/medical laser Device type Non-invasive active therapeutic Model PROSERIES Class Electrical classification Type B Laser class IP classification IP20 Battery type Lithium-ion (Li-Ion) Internal power source Secondary Lithium-ion battery Supply voltage Li-Ion battery charger with a secondary nominal output voltage of 7.4 VDC ±...
  • Page 48 INSTRUCTION MANUAL FOR PROSERIES MEDICAL LASER Coating Powder paint Notified body nr. CE-mark CE 0413 The product is CE marked in accordance to the requirements of MDD 93/42/EEC...

  • Page 49: Technical Specifications (Laser)

    INSTRUCTION MANUAL FOR PROSERIES MEDICAL LASER 13. TECHNICAL SPECIFICATIONS (GENERAL) 13.1 Laser Diode for Laser Probe 904 nm Laser type GaAs Wavelength(s) 904 nm ± 10 nm Type of radiation Infrared A, invisible Beam type Divergent Beam divergence 9x25 deg (FWHM) or ~ 0.44 rad Spot size (at contact application) 5 mm in diameter (19.5 mm²) Continuous or pulsed laser...

  • Page 50: Laser Diode For Laser Probe 635 Nm 100Mw

    INSTRUCTION MANUAL FOR PROSERIES MEDICAL LASER NOHD <0.8 m Protective eyewear Minimum OD+3 at 904 nm ± 20 nm 13.2 Laser Diode for Laser Probe 635 nm 100 mW Laser type AlGaInP Wavelength(s) 637 nm ± 5 nm Type of radiation Red, visible Beam type Divergent...

  • Page 51: Laser Diode For Laser Probe 635 Nm 400 Mw

    INSTRUCTION MANUAL FOR PROSERIES MEDICAL LASER 13.3 Laser Diode for Laser Probe 635 nm 400 mW Laser type AlGaInP Wavelength(s) 637 nm ± 5 nm Type of radiation Red, visible Beam type Divergent Beam divergence 8.5 x 33 grader (FWHM) eller ~ 0.57 rad Spot size (at contact application) 9 mm in diameter (63.5 mm²) Continuous or pulsed laser...

  • Page 52: Laser Diode For Laser Probe 808 Nm

    INSTRUCTION MANUAL FOR PROSERIES MEDICAL LASER 13.4 Laser Diode for Laser Probe 808 nm Laser type GaAlAs Wavelength(s) 808 nm ± 3nm Type of radiation Infrared A, invisible Beam type Divergent Beam divergence 10x40 deg (FWHM) or ~ 0,7 rad Spot size (at contact application) 9 mm in diameter (63,5 mm²) Continuous or pulsed laser...

  • Page 53: Definitions

    INSTRUCTION MANUAL FOR PROSERIES MEDICAL LASER 14. DEFINITIONS Terms Description Non-invasive treatment A treatment procedure that does not break the skin or come in contact with mucosa or internal body cavities through any natural or artificial orifices. Laser aperture The opening from which laser radiation is emitted. Laser diode The component that produces and emits laser radiation.
  • Page 54 INSTRUCTION MANUAL FOR PROSERIES MEDICAL LASER LASER Laser is an acronym for Light Amplification by Stimulated Emission of Radiation. LED is an acronym for Light Emitting Diode (used as indicators). Terms Description Accompanying documents Documents and information for the responsible organization or operator regarding the medical electrical equipment, particularly about basic safety and essential performance.
  • Page 55 INSTRUCTION MANUAL FOR PROSERIES MEDICAL LASER Operator Person handling the equipment. Patient Living being (person or animal) undergoing a medical, surgical or dental procedure. Responsible organization Entity accountable for the use and maintenance of a medical electrical equipment or system. For example a hospital, an individual clinician or a layperson.

  • Page 56: Labels And Symbols

    INSTRUCTION MANUAL FOR PROSERIES MEDICAL LASER 15. LABELS AND SYMBOLS Symbol/label/sign Description Warning sign close to the apertures through which laser radiation in excess of the AEL for Class 1 or Class 2 is emitted. Explanatory label. The name and publication date of the standard to which the product has been classified. The product is described on the explanatory label by a statement concerning the maximum output of laser radiation, the pulse duration (if applicable), and the emitted wavelength(s).
  • Page 57 INSTRUCTION MANUAL FOR PROSERIES MEDICAL LASER Stop (of action). To identify the control by means of which an action is stopped, i.e., stop of laser emission. Follow instructions for use. Consult the accompanying documents before use or action. Step-Up / Step-Down control function symbols. Used together with Time Set, Joule Set, Frequency Set.

  • Page 58: Labels And Markings On The Product

    INSTRUCTION MANUAL FOR PROSERIES MEDICAL LASER Battery check status. “Recharge battery” Battery is about to become depleted. The operator is instructed to recharge the battery. Interlock. NOTE. Reference for symbols. IEC60825-1:2014 and IEC60878:2003 15.1 Labels and Markings on The Product These are legible reproductions of the labels and hazard warnings affixed to the device.

  • Page 59: Symbols And Marking On Package Label

    INSTRUCTION MANUAL FOR PROSERIES MEDICAL LASER 15.2 Symbols and Marking on Package Label...

  • Page 60: Limitation Of Liability

    INSTRUCTION MANUAL FOR PROSERIES MEDICAL LASER 16. LIMITATION OF LIABILITY SYMBYX PTY LTD and Spectro Analytic Irradia AB disclaim any liability for personal injury or damages to property or possessions that occur as a consequence of the following circumstances: • Use of the device that is not in accordance with its normal or intended use.

  • Page 61: Disposal And Recycling Of The Device

    INSTRUCTION MANUAL FOR PROSERIES MEDICAL LASER 17. DISPOSAL AND RECYCLING OF THE DEVICE The device should be disposed of in a proper and environmentally safe way. The device and batteries that are no longer usable should be sent back to the supplier for proper disposal or to a company specialized in the disposal of hazardous electrical materials and batteries.

  • Page 62: Transport And Packaging Of The Device And/Or Battery Housing

    INSTRUCTION MANUAL FOR PROSERIES MEDICAL LASER 18. TRANSPORT AND PACKAGING OF THE DEVICE AND/OR BATTERY HOUSING Save and use the original package which the device was delivered in for transport and storage. During transport or storage, the key should be removed from the key switch of the device. The device should be stored/transported within the temperature range of -20 to + 50ºC, 5-95% humidity and 540-1060hPa air pressure, and placed in a dry package that protects the device from vibrations, impacts and shock.

  • Page 63: Manufacturer Contact Information

    19.1 Reporting serious incidents Any serious incident that has occurred in relation to the device should be reported by the user and/or patient to SYMBYX Pty Ltd (above) and the competent authority of the Member State in which the user and/or patient is established.

  • Page 64: Electromagnetic Compatibility (Emc)

    INSTRUCTION MANUAL FOR PROSERIES MEDICAL LASER 20. ELECTROMAGNETIC COMPATIBILITY (EMC) The need for establishing the electromagnetic compatibility in standards is to ensure that the performance of Medical Electrical Equipment, under certain conditions, can be expected to be normal. Electromagnetic emission standards are essential for, inter alia, the protection of safety services and other Medical Electrical Equipment and Systems, as well as telecommunications.

  • Page 65: Electromagnetic Immunity - Guidance And Declaration

    INSTRUCTION MANUAL FOR PROSERIES MEDICAL LASER RF emissions CISPR 11 Group 1 The ProSeries uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. RF emissions CISPR 11 Class B The ProSeries is suitable for use in all...
  • Page 66 INSTRUCTION MANUAL FOR PROSERIES MEDICAL LASER Voltage dips, short <5 % UT <5 % UT Mains power quality should be that of a typical interruptions and voltage (>100 % dip in UT) (>100 % dip in UT) for 0,5 commercial hospital environment. If the user of variations on power for 0.5 periods periods...
  • Page 67 INSTRUCTION MANUAL FOR PROSERIES MEDICAL LASER Guidance and manufacturer’s declaration – electromagnetic immunity The ProSeries is intended for use in the electromagnetic environment specified below. The customer or the user of the ProSeries should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level...

  • Page 68: Separation Distances - Portable And Mobile Rf Communications

    INSTRUCTION MANUAL FOR PROSERIES MEDICAL LASER NOTE 1 At 80MHz and 800MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflected from structures, objects and people. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy.
  • Page 69 INSTRUCTION MANUAL FOR PROSERIES MEDICAL LASER For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

  • Page 70: Applied Standards

    INSTRUCTION MANUAL FOR PROSERIES MEDICAL LASER 21. APPLIED STANDARDS IEC 60601-1:2005+A1, IEC 60601-2-22:2007+A1, IEC 60825-1:2014, IEC 60601-1-6:2010+A1, IEC 62366:2007+A1, IEC 62304:2006, IEC60601-1-2: 2007 & 2014, ANSI/AAMI ES60601-1:2005, CAN/CSA-C22.2 No. 60601-1:08. National differences for Korea and Japan. Other standards with which the device complies with: ISO14971:2019, ISO10993-5, ISO10993-10.

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