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SYMBYX PDCare Instruction Manual

904 nm laser
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INSTRUCTION MANUAL
PDCare 904 nm Laser by SYMBYX

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Summary of Contents for SYMBYX PDCare

  • Page 1 INSTRUCTION MANUAL PDCare 904 nm Laser by SYMBYX...

  • Page 2: Table Of Contents

    CONTENTS General information ..........................7 Product description ..........................7 Separate power supply source (mains supply transformer) ............. 8 Essential performance and basic safety ....................8 Temperature range for use ........................8 User restrictions ............................8 General caution and warning statements .................... 8 Device description and use ........................
  • Page 3 Description ............................. 14 Expected life before service required ..................14 6.1.1 Medical purpose/intended use ......................14 Patient ..............................14 Operator ..............................14 Application ............................. 14 Environment ............................14 Home healthcare environment ....................15 6.6.1 Frequency of device use ........................15 Treatment/application time per patient ....................
  • Page 4 Intended OPERATOR ........................19 6.16 Operator responsibilities ........................19 6.17 Responsible organization ........................ 20 6.18 Patient position ..........................20 6.19 Training ............................... 21 6.20 General battery safety information ....................22 Battery safety ............................22 Warnings and precautions ........................22 Recycling of batteries ........................... 23 Replacement of batteries ........................
  • Page 5 ON/OFF .............................. 31 10.2 11 Technical specifications (general) ....................32 12 Technical specifications ........................33 PDCare Laser 904 nm by SYMBYX ....................33 12.1 13 Definitions ............................34 14 Labels and symbols ......................... 36 Labels on the device ......................... 37 14.1...
  • Page 6 19 Electromagnetic compatibility (EMC) ....................39 Electromagnetic emissions – guidance and declaration ............. 40 19.1 Electromagnetic immunity – guidance and declaration ............... 41 19.2 Separation distances – portable and mobile RF communications ..........43 19.3 20 Applied standards ..........................43...

  • Page 7: General Information

    “WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the PDCare 904 nm Laser by SYMBYX, including cables specified by the manufacturer.

  • Page 8: Separate Power Supply Source (Mains Supply Transformer)

    1.2 Separate power supply source (mains supply transformer) Not used. 1.3 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 normal and intended use. 1.4 Temperature range for use Discharge of batteries: 10 - 90 % atmospheric humidity at temperatures ranging from +5 - 30°...

  • Page 9: Operation Description Of Laser Treatment (General)

    modality intended to be operated by the patient for HOME CARE. The treatment modality of medical laser devices is commonly called Low Level Laser Therapy (LLLT), photobiomodulation, or cold (non-thermal) laser therapy, when used for reducing pain and inflammation, Parkinson’s and Fibromyalgia symptoms, as well as to promote tissue repair and recovery. 2.1 Operation description of laser treatment (general) Treatment is performed by applying a generally optimal dose of laser energy in contact mode onto and around a condition, using a point-by-point application procedure by holding the device in position, and switching application point at each signal.

  • Page 10: Device Overview

    2.3 Device overview...
  • Page 11 The blue light indicate that the laser is active. After seconds of treatment the device’s front light will blink and a sound Press On/Off button to will be heard, indicating that turn on the device. Press against the you should move the laser The green light indicates skin to activate the device to a new treatment...

  • Page 12: Primary Operating Functions

    Primary operating functions Press and release the push-button switch to put the device in operational mode (unlocking the device for use). The device enters a 2.5 seconds STAND-BY state. A green light emitting diode on the push-button switch indicates the device enters to a ready state.

  • Page 13: Treatment Controls

    3.6 J 1.8 J/cm² Laser by SYMBYX (2 x 30 mW) NOTE. Contact pressure of 1 to 5 N (Newton) is recommended for the operator when pressing the device against the skin to remove blood from the tissue (in the same way as when a finger is pressed onto the skin creating a paler spot), which thereby increases the transmission or penetration of the laser light.

  • Page 14: Device Application Specification

    Device application specification 6.1 Description The device is a transportable, hand-held and battery powered medical laser with which the operator administers non-invasive laser light/radiation to a patient. 6.1.1 Expected life before service required Three to four years. 6.2 Medical purpose/intended use Intended to reduce pain and inflammation, Parkinson’s and Fibromyalgia symptoms, as well as to promote tissue repair.

  • Page 15: Home Healthcare Environment

    Do not use the device at locations or environments with a high atmospheric humidity, such as saunas, swimming baths and shower rooms etc. Do not use the device in ambient light or when performing safety-critical work due to the lasers potential to cause dazzle effect or flash blindness.

  • Page 16: Treatment/Application Time Per Patient

    Elbow Shoulder Neck *Please refer to separate Parkinson’s treatment protocols, available directly from SYMBYX Please read the above table in conjunction with Chapter 6.14 Patient potential reaction for first time users. 6.9 Treatment interval Approximately every 48 hours, depending if condition is chronic or acute.

  • Page 17: Treatment Session Interval

    6.11 Treatment session interval Continuously. 6.12 Contraindications Treatment of the eye through the lens; intra-beam viewing. 6.13 Side effects No known side effects. 6.14 Patient potential reaction When treating acute conditions, the pain relief may cause stress or damage if the patient returns to normal activities before the condition has fully recovered.

  • Page 18: Patient Population

    6.15 Patient population a) Age: > 18 to geriatric. b) Weight: Not relevant. c) Height: Not relevant. d) Gender: Not relevant. e) Pregnancy: Not recommended. Avoid treatment of the abdominal region. There is, however, no evidence of any known risks for either the mother or fetus.

  • Page 19: Intended Operator

    6.16 Intended OPERATOR 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. PATIENT operator An OPERATOR who is instructed by, and under the guidance of, an ordinary OPERATOR in how to perform self- treatment.

  • Page 20: Responsible Organization

    § Be responsible for educating, instructing and surveying a PATIENT operator. § Be responsible for the use of correct eye protection wear (if necessary). § Be responsible for contacting the manufacturer or its representative when further education or training is required, as well as with questions regarding service.

  • Page 21: Training

    Exposure of the abdomen during pregnancy; treatment should be avoided due to legal reasons, i.e. that the operator could be accused should any complications arise; Certain blood diseases; haematological diseases include, on the one hand, mild hypochromic anaemia and, on the other hand, life-endangering myeloblastic leukaemia.

  • Page 22: General Battery Safety Information

    General battery safety information Do not use rechargeable batteries such as NiCd, NiMH, Li-Ion. This product is intended for non-rechargeable LR03 AAA 1.5 V batteries. The batteries are placed inside the device and only accessible by use of a tool. To ensure safety when removing or replacing the batteries the device must be turned off, i.e.

  • Page 23: Recycling Of Batteries

    § Do not strike or throw the device containing batteries. The impact may cause battery fluid leakage, explosion or fire. § Do not use the device if the enclosure is damaged or deformed. A damaged enclosure may have caused damage to the batteries, which could result in battery fluid leakage, explosion or fire.

  • Page 24: Replacement Of Batteries

    7.4 Replacement of batteries The operator should not touch the patient while removing the batteries, unless the operator is the patient. Use LR03 AAA 1.5 V batteries. Do not use rechargeable batteries such as NiCd, NiMH, Li-Ion. If the screw is missing, contact the manufacturer/supplier for replacement/spare screw, and do not use the device until the screw is in position.

  • Page 25: Transport And Storage Of The Device

    After changing batteries attach the cover 7.5 Transport and storage of the device Ensure that the push-button (ON/OFF) is switched off. Do not carry or store removed batteries 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 26: Laser Safety

    Laser safety 8.1 General laser safety information These instructions for use are intended to minimize hazardous situations and the risk of potential harm. They include such things as: Safe handling and use of the device; Safe storage and transportation of the device; Use and descriptions of correct protective eyewear (i.e.

  • Page 27: General Risks With Class 1 Lasers (See Chapter 2.2) Iec 60825-1

    seconds. The transition from stand-by to ready is possible while the laser emission control button is pressed (i.e placed onto skin); however, no emission of laser radiation will occur. Laser emission is started by the laser emission start/stop control button (i.e. placed in contact with the skin). When the emission of laser radiation starts, the operator is informed by a clear audible signal and the lighting of the blue LEDs.

  • Page 28: Protective Eyewear. Personal Protective Equipment (Optional Requirement)

    to check that the laser emits laser radiation in those cases where there is no power meter available and the operator needs to ensure that the device is functioning. WARNING: Do not look at direct or non-diffuse reflections and avoid intra-beam viewing. The operator/patient may choose to use correct protective eyewear to minimize unintentional exposure.

  • Page 29: Visual Inspections

    disinfectants on cotton pads, with isopropyl alcohol, in order to prevent the risk of contaminants impairing the optical path, as well as to minimize patient cross-contamination. Excessive use of cleaning or disinfectants will in time damage the coating and color on the product.

  • Page 30: Information For Service Technicians

    9.3 Information for service technicians 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 31: Description Of Controls, Messages, And Indicators

    10 Description of controls, messages, and indicators When pressed into contact with surface (the skin), the laser diodes are activated and starts to emit laser radiation 10.1 Laser through the laser aperture. A single audible signal indicates “start of action” and laser emission. emission A laser aperture LED is illuminated to indicate emission of laser radiation control...

  • Page 32: Technical Specifications (General)

    11 Technical specifications (general) Product Medical electrical equipment Type Therapeutic laser/medical laser Device type Non-invasive active therapeutic Model PDCare 904 nm Medical Laser Electrical classification Type BF Laser class IP classification IP22 Battery type LR03 AAA 1.5 V non-rechargeable Internal power source 6 pcs primary LR03 AAA 1.5 V battery...

  • Page 33: Technical Specifications

    12 Technical specifications 12.1 PDCare Laser 904 nm by SYMBYX 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) 9 mm in diameter (63.5 mm²)

  • Page 34: Definitions

    13 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 35 Terms Description Accompanying Documents and information for the responsible organization or operator regarding the medical electrical equipment, documents 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...

  • Page 36: Labels And Symbols

    14 Labels and symbols Symbol/label/sign Description Avoid intra beam viewing. Do not look into the beam Laser aperture Warning: laser beam To warn of laser beam hazards Switch the device “ON” or “OFF” To indicate connection or disconnection. Each position, “ON” or “OFF”, is a stable position Start (of action) To identify the control by means of which an action is started, i.e.

  • Page 37: Labels On The Device

    14.1 Labels on the device These are legible reproductions of the labels and hazard warnings affixed to the device.

  • Page 38: Symbols And Marking On Package Label

    14.2 Symbols and marking on package label 15 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: •...

  • Page 39: Distributor And Manufacturer Contact Information

    +20° C for 45 minutes, before use and application. 18 Distributor and manufacturer contact information Distributor: SYMBYX Pty Ltd. ABN 29638049073 Suite 6, 110-114 Hampden Lane, Artarmon NSW 2064 Australia. Tel +61 (0)2 8066 9966 Email: info@symbyxbiome.com.

  • Page 40: Electromagnetic Emissions - Guidance And Declaration

    Guidance and manufacturer’s declaration – electromagnetic emissions The PDCare 904 nm Laser by SYMBYX is intended for use in the electromagnetic environment specified below. The customer or the user of this laser should assure that it is used in such an environment.

  • Page 41: Electromagnetic Immunity - Guidance And Declaration

    Guidance and manufacturer’s declaration – electromagnetic immunity The PDCare 904 nm Laser by SYMBYX is intended for use in the electromagnetic environment specified below. The customer or the user of this laser should assure that it is used in such an environment.
  • Page 42 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 PDCare 904 nm Medical Laser is used exceeds the applicable RF compliance level above, the PDCare 904 nm laser should be observed to verify normal operation.

  • Page 43: Separation Distances - Portable And Mobile Rf Communications

    Laser by SYMBYX The PDCare 904 nm Laser by SYMBYX is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the laser can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the laser as recommended below, according to the maximum output power of the communications equipment.

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