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Related Manuals for SYMBYX DuoCare 904
Summary of Contents for SYMBYX DuoCare 904
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Page 2: Table Of Contents
Contents General information ............................8 Product description ............................8 Separate power supply source (mains supply transformer) ............... 9 Essential performance and basic safety ...................... 9 Temperature range for use indoors/outdoors: ................... 9 User restrictions ............................9 General caution and warning statements ....................9 Device description and use .......................... - Page 3 Overview chart of the treatment controls ....................16 Treatment examples..........................17 Treatment adjustments ............................. 17 Skin phototype, hair colors........................17 Skin types, body modifications, tattoo colors ................... 18 Body constitution ............................19 Medical recording .............................. 19 Device application specification ........................20 Description ..............................
- Page 4 7.10 Number of treatments per patient ......................21 7.11 Treatment session interval ........................21 7.12 Contraindications............................21 7.13 Side effects ..............................21 7.14 Patient reaction ............................21 7.15 Patient population ............................. 22 7.16 Intended OPERATOR ..........................23 7.17 Operator responsibilities ........................... 23 7.18 Responsible organization ..........................
- Page 5 Laser safety ................................ 31 General laser safety information ....................... 31 Class 3B potential hazards ......................... 32 Maintenance and control of emitted output power ................. 32 Protective eyewear. Personal protective equipment ................34 General electrical and mechanical safety...................... 34 10.1 Cleaning/disinfection procedures ......................34 10.2 Visual inspections ............................
- Page 6 “deep” ................................... 38 11.6 One Joule control ............................38 “1J” ..................................38 11.7 Audible information signal control ......................39 “sound mute”................................. 39 11.8 Visible information signal indicator ......................39 11.9 Battery status indicator ..........................39 11.10 ..................................39 11.11 Laser emission control ........................... 40 Technical specifications (general) .........................
- Page 7 Electromagnetic compatibility (EMC) ......................49 20.1 Electromagnetic Emissions – guidance and declaration ................50 20.2 Electromagnetic Immunity – guidance and declaration ................51 20.3 Separation distances – portable and mobile RF communications .............. 53 Applied standards ............................54...
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Page 8: General Information
General information This operating and user manual applies to the DuoCare 904 Laser by SYMBYX. This laser device is manufactured for SYMBYX Pty Ltd of Australia by Spectro Analytic Irradia AB of Sweden. Note: Irradia also manufacture an identical product called the MID-Lite Laser. -
Page 9: Separate Power Supply Source (Mains Supply Transformer)
Separate power supply source (mains supply transformer) This device is specified to be connected only to the Lithium-Ion battery charger, Model 2241Li from Mascot. Essential performance and basic safety The device does not have an essential performance, the absence of which may result in an unacceptable risk. Basic safety is maintained when the device is stored, handled, and operated in normal condition, and in accordance with its normal use and intended use. -
Page 10: Device Description And Use
Device description and use This device is a transportable, hand-held and battery-operated medical laser product, with which the operator administers non-invasive transient class 3B infrared 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)
Operation description of laser treatment (general) Treatment is performed by applying a generally optimal dose of laser energy onto and around a condition, using a point-by-point application procedure. An audible and visible signal informs the operator when to switch application point. At each signal, the laser aperture is moved ~ 1. 5 cm until the whole condition area has been covered. -
Page 12: Device Overview
Device overview... -
Page 13: Primary Operating Functions
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 device). -
Page 14: Charging Of The Battery
Failure of charger, battery or the connector. Contact service for support. If the Light Emitting Diode on the charger is not lit – neither green nor orange – then the charger is not functioning as intended. Contact SYMBYX customer service for support via info@symbyxbiome.com. -
Page 15: Treatment Controls
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) are shown on the LCD display. -
Page 16: Overview Chart Of The Treatment Controls
Overview chart of the treatment controls The treatment controls overlap each other. There is no risk of harm using one control instead of another. The operator is advised to use the control they find most suitable or which corresponds best to the condition being treated. The following controls are guidelines only. Treatment Parameters per application point Treatment Depth of... - Page 17 IMPORTANT! New patients using laser treatment for the first time should commence at a lower dose and/or treatment time to evaluate reaction. For some patients suffering complex pain conditions, the laser treatment may cause in rare cases a transient increased pain. SYMBYX recommends a maximum of 30...
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Page 18: Treatment Examples
Treatment examples The apertures of the device cover a surface area of 4-5 cm², and are moved approximately 1.5-2 cm at each signal. A treatment area of 10 cm² is covered after 1-2 signals. The examples in the chart below are general guidelines based on patients with normal height and body fat, and with skin phototype I-III. -
Page 19: Treatment Adjustments
Treatment adjustments Skin phototype, hair colors Skin pigmentation varies with the amount of melanin 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, darker brown and black skin and hair are more easily burned due to the absorption of light in melanin. -
Page 20: Body Constitution
Body constitution The patient’s body constitution may influence the dose of laser energy needed to achieve the most efficient results. In the chart below, general guidelines are described for adjusting the treatment. This chart only applies when treating conditions or disorders that are not superficially or externally situated, such as wounds. -
Page 21: Device Application Specification
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 radiation to a patient. Medical purpose Reduce acute and chronic pain and inflammation, as well as to promote tissue repair. Patients Humans and animals. -
Page 22: Frequency Of Device Use
Frequency of device use Up to 20 times a day. Treatment/application time per patient 30 seconds to 30 minutes; normally 5 - 20 minutes per treatment. Treatment interval Normally once every 24-72 hours. The treatment interval can be longer, such as once every two to four weeks. Chronic conditions 1 to 3 times a week. -
Page 23: Patient Population
Patient population 7.15 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 fetus. Nationality: Not relevant Skin color: Light or slightly pigmented. -
Page 24: Intended Operator
Intended OPERATOR 7.16 Ordinary operator An OPERATOR who is medically trained and instructed in the use of the device, and who uses the device in a day-to-day practice. The OPERATOR performs treatments on PATIENTS. Temporary operator An OPERATOR who is instructed by, and under the surveillance of, an ordinary OPERATOR in how to perform a specific self-treatment procedure for a limited period of time. -
Page 25: Responsible Organization
Operator contact with the device The operator sits or stands and uses at least one hand to control and operate the device The operator manages the device with dry or normal hand skin condition or with protective gloves Neither hands nor gloves should have been in contact with any oils, creams, lotions, balms, moisturizers, etc. Oils and creams etc. might damage electrical or mechanical components. -
Page 26: Training
Heavy blood losses; treatment should be avoided due to the vasodilating effect of the laser light. Neuropathies; the analgesic effect of laser therapy can potentially reduce the sensitivity of proprioceptors in the skin. Therefore, caution is necessary regarding neuropathies, since the application of laser therapy may reduce existing minimum sensitivity with a danger of damaging the given region. - Page 27 used as a MOP (Means of Protection). By using a specified non-standard connector, the risk of connecting the device to the wrong charger is greatly reduced. The connector selected can be connected in only one way, reducing the risk of reversed polarity. The charger used is in compliance with IEC60601-1.
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Page 28: Battery Safety
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 29: Recycling Of Batteries
▪ Do not disassemble the Lithium-ion batteries. Doing so can damage the protection circuit or protective safeguards, which may cause an internal or external short circuit. It may also cause battery fluid leakage, heat generation, explosion or fire. ▪ Do not strike or throw the device containing the lithium-ion battery or the battery housing. The impact may cause battery fluid leakage, explosion or fire. -
Page 30: Replacement Of Battery
Replacement of battery Ensure that the key switch has been removed and that the device is turned off (e.g., no LED indicators are lit). Remove the two screws by using a matching screw driver. Pull out the battery housing from the laser head. The screws used are M2.5 countersunk. -
Page 31: Transport And Storage Of The Battery Housing
Transport and storage of the battery housing Ensure that the push-button (ON/OFF) and the key switch are turned off and that the key has been removed. Do not carry or store a disconnected battery housing together with metal necklaces, hairpins, or other electrically conductive materials. This may short circuit the battery, which could result in excessive current flow and possibly battery fluid leakage, heat generation, explosion or fire. -
Page 32: Laser Safety
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: Safe handling and use of the device Safe storage and transportation of the device NOHD distance Use and descriptions of correct protective eyewear (i.e., wavelength range and optical density OD+) -
Page 33: Class 3B Potential Hazards
The device is equipped with a stand-by/ready function. The device enters stand-by when the key switch is turned to the “ON” position. In the “ON” position, the yellow LED next to the key switched is activated. The transition to “ready” is clearly indicated by repeated audible signals and the flashing of the LEDs on the laser aperture and keypads. - Page 34 Important notes regarding periodic measurements of the output power: The power meter must be able to: measure the wavelengths that the laser emits measure output powers of at least 1000 mW (or 1 W) In addition, the following routines should be adhered to: Ensuring that the aperture lenses are clean before measuring the output power (dirty lenses may reduce the output power by absorption and cause discomfort due to the heat generated) The power meter should be placed in contact with, or very close to, the laser aperture to ensure that the whole beam is fitted onto the...
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Page 35: Protective Eyewear. Personal Protective Equipment
Protective eyewear. Personal protective equipment Optical density should be minimum +3 (OD+3), which means that 1/1000 of the light passes through the protective eyewear. The power of a 0.5 W laser is reduced to 0.5 mW by using protective eyewear with OD+3. Through the proper use of protective eyewear by both patients and operators, the possibility of eye injuries caused by laser radiation is reduced to a minimum. -
Page 36: Visual Inspections
Visual inspections 10.2 The operator should perform a visual inspection of the device before use and contact the supplier or manufacturer for support or service in any case where real or perceived changes in the performance of the device occur. To ensure a safe inspection, follow the instructions below: Inspection Potential problem Action to be taken... -
Page 37: Information For Service Technicians
Information for service technicians 10.3 Upon request by the servicing personnel, appropriate instructions for service adjustments and procedures for each laser model are only provided in a specified service manual. To ensure safe service and safe usage after service, as well as guaranteeing that the high-quality standard of the product remains intact, service of the device should only be performed by a service technician authorized by the manufacturer. -
Page 38: 11 Description Of Controls, Messages, And Indicators
11 Description of controls, messages, and indicators The LCD display shows the treatment time and the number of joules applied on a condition. [Time] 00:00 11.1 LCD-display [Joules] 00.0 J The treatment time is displayed in hours, minutes and seconds. Every second that the laser(s) is activated is registered on the timer. -
Page 39: Treatment Control
This treatment control is used to deliver a generally optimal dose of laser energy for conditions that are situated intermediately in the tissue. 11.4 Treatment The output power of the laser diodes is set to 60 mW, delivering 3.6 J (joules) per aperture and treatment control point. -
Page 40: Audible Information Signal Control
This control allows the operator to mute the audible information signal both before and during laser emission. If pressed once, 11.7 Audible the audible signal is muted. When pressed again, the audible signal is reactivated. The audible signal is always reset to “ON” when information the device is restarted by the push-button or the key switch. -
Page 41: Laser Emission Control
When pressed and released once, the laser(s) is activated and starts to emit laser radiation through the laser aperture. A single audible signal indicates “start of action” and laser emission. 11.11 Laser emission A blue laser aperture LED is illuminated for each corresponding aperture emitting laser radiation. control When pressed and released again, the laser(s) stops emitting laser radiation through the laser aperture. -
Page 42: Technical Specifications (General)
Technical specifications (general) Product Medical electrical equipment Type Therapeutic laser/medical laser Device type Non-invasive active therapeutic Model DuoCare 904 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 43: Technical Specifications (Laser)
Technical specifications (laser) Laser type GaAs (gallium arsenide) Wavelength(s) 904 nm ± 10 nm Spectral bandwidth ± 2nm Type of radiation Infrared A, invisible Beam type Divergent Beam divergence 10x40 deg (FHWM) or ~ 0.7 rad Source size 200 µm Spot size (at contact application) <... -
Page 44: Definitions
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 Laser light... - Page 45 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 Active therapeutic device The operation of the device depends on an electrical energy source, and is used for the treatment or alleviation of injuries and diseases Applied part The part of the medical electrical equipment that in normal use comes into physical contact with the patient during treatment...
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Page 46: Labels And Symbols
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) Warning: laser beam... - Page 47 The WEEE symbol Indicating a separate collection for WEEE products, i.e., waste electrical and electronic equipment Control button: 1 joule Audible and visible signals for each delivered joule per activated aperture Superficial Control button for superficial treatment Output power and joules are set for the abovementioned tissue depth Control button for low treatment Output power and joules are set for the abovementioned tissue depth Intermediate...
- Page 48 Labels on the device These are legible reproductions of the labels and hazard warnings affixed to the device.
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Page 49: Limitation Of Liability
Limitation of liability SYMBYX Pty Ltd disclaims 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 50: Electromagnetic Compatibility (Emc)
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 51: Electromagnetic Emissions - Guidance And Declaration
20.1 Guidance and manufacturer’s declaration – electromagnetic emissions The DuoCare 904 is intended for use in the electromagnetic environment specified below. The customer or the user of the DuoCare 904 should assure that it is used in such an environment. -
Page 52: Electromagnetic Immunity - Guidance And Declaration
Electromagnetic Immunity – guidance and declaration 20.2 Guidance and manufacturer’s declaration – electromagnetic immunity The DuoCare 904 is intended for use in the electromagnetic environment specified below. The customer/user of the device should assure that it is used in such an environment. Immunity test... - Page 53 To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the DuoCare 904 is used exceeds the applicable RF compliance level above, the DuoCare 904 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the DuoCare 904.
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Page 54: Separation Distances - Portable And Mobile Rf Communications
Recommended separation distances between portable and mobile RF communications equipment and the DuoCare 904 The DuoCare 904 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The user of the DuoCare 904 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the DuoCare 904 as recommended below.
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