SYMBYX DermaCare 635 Instruction Manual

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INSTRUCTION MANUAL

DermaCare 635 nm Laser by SYMBYX

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Summary of Contents for SYMBYX DermaCare 635

Page 1 INSTRUCTION MANUAL DermaCare 635 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 ............................. 13 Expected life before service required ....................14 Medical purpose/intended use ......................14 Patient ..............................14 Operator ..............................14 Application ............................. 14 Environment ............................14 Home healthcare environment ......................14 Frequency of device use ........................15 Treatment/application time per patient (pain & inflammation only) ........... 15 9.10 60 seconds per application point.
Page 4 Patient population ..........................17 9.17 Intended OPERATOR ........................18 9.18 Operator responsibilities ........................18 9.19 Responsible organization ........................ 19 9.20 Patient position ..........................19 9.21 Training ............................... 20 9.22 10 General battery safety information ....................21 Battery safety ............................. 21 10.1 Warnings and precautions .......................
Page 5 ON/OFF .............................. 29 13.2 14 Technical specifications (general) ....................30 15 Technical specifications ........................31 DermaCare Laser 635 nm by SYMBYX ..................31 15.1 16 Definitions ............................32 17 Labels and symbols ......................... 34 Labels on the device ......................... 35 17.1...
Page 6 23 Reporting serious incidents ......................37 24 Electromagnetic compatibility (EMC) ....................37 25 Electromagnetic emissions – guidance and declaration ..............38 Electromagnetic immunity – guidance and declaration ............... 38 25.1 Separation distances – portable and mobile RF communications ..........40 25.2 26 Applied standards ..........................
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 DermaCare 635 nm Laser by SYMBYX, including cables specified by the manufacturer.
Page 8: Separate Power Supply Source (Mains Supply Transformer)
Separate power supply source (mains supply transformer) Not used. 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. 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, as well as to promote tissue repair and recovery. 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
Device overview...
Page 11 The light indicates 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
60 s 3 J/cm² Laser by SYMBYX (2 x 50 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 Expected life before service required Three to four years. Medical purpose/intended use Intended to reduce pain and inflammation, as well as to promote tissue repair. Patient Human. Operator Ordinary and patient operators: - An ordinary operator is a medically trained practitioner who uses medical lasers in his or her day-to-day practice; and - A patient operator uses the device according to the accompanying documents (this manual) for home care self-treatment with guidance or instruction from a non-present ordinary operator.
Page 15 Damaged or deformed parts of the enclosure or the applied part and lenses caused by pets or children may cause discomfort or negligible skin injury. Inspect the device before use (see chapter 9.2). Keep the device stored in a location not accessible to pets, pests and children.
Page 16 of treatment due to either the commencement of the healing process, the chronic condition turning to acute, or the relaxation of tense muscles. The patient may become tired or sleep longer than normal after treatment due to pain relief and muscle relaxation. Patients should not, in these cases, perform any activities that require a high level of concentration or alertness.
Page 17: Patient Population
9.17 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 18: Intended Operator
9.18 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 19: Responsible Organization
§ 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. Operator contact with the device The operator sits or stands and uses at least one hand to control and operate the device;...
Page 20: Training
Certain blood diseases; haematological diseases include, on the one hand, mild hypochromic anaemia and, on the other hand, life-endangering myeloblastic leukaemia. Laser therapy does not affect the length of life of blood cells, and there is no basis for avoiding its application in any field, with the exception of irradiating hemopoietic bone marrow;...
Page 21: General Battery Safety Information
10 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 22: Recycling Of Batteries
§ 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. § If leaked electrolyte comes into contact with the eyes, flush the eyes immediately with clean water and seek medical attention.
Page 23: Replacement Of Batteries
10.4 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 24: Transport And Storage Of The Device
After changing batteries attach the cover 10.5 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 25: Laser Safety
11 Laser safety 11.1 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 26: General Risks With Class 3R Lasers According To Iec 60825-1. See Chapter 2.2 Of This Manual
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. The audible indicator indicates continuous emission by repeatable signals.
Page 27: Protective Eyewear. Personal Protective Equipment (Optional Requirement)
“WARNING: No modifications of this equipment are allowed.” This warning statement addresses the issue that HAZARDS can result from an unauthorized modification of the ME EQUIPMENT, e.g. BASIC SAFETY may be compromised by a modification or an alteration of the normal condition of the device. 11.4 Protective eyewear.
Page 28: Visual Inspections
12.2 Visual inspections The operator should perform a visual inspection of the device before use and contact the distributor 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 described below: Inspection Potential problem...
Page 29: Description Of Controls, Messages, And Indicators
A list of controls and procedures, implementable by persons other than the manufacturer or his or her agents, which increase the exposure to possible battery failure and similar hazards; Protective procedures for service personnel; and legible reproductions (color is optional) of required labels and hazard warnings. The following can be supplied upon request: Wire schematic, wire schematic component part lists, descriptions, calibration instructions or any other information that will assist in repairing the parts of the device that have been designated by the manufacturer as repairable by external service personnel.
Page 30: Technical Specifications (General)
14 Technical specifications (general) Product Medical electrical equipment Type Therapeutic laser/medical laser Device type Non-invasive active therapeutic Model DermaCare 635 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 Current consumption <...
Page 31: Technical Specifications
15 Technical specifications DermaCare Laser 635 nm by SYMBYX 15.1 Laser type AlGaInP Wavelength(s) 635 nm ± 5 nm Type of radiation Red, visible Beam type Divergent Beam divergence 8,5x33 grader (FWHM) or ~ 0,57 rad Spot size (at contact application) 9 mm in diameter (63,5 mm²)
Page 32: Definitions
16 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 33 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 34: Labels And Symbols
17 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 35: Labels On The Device
Labels on the device 17.1 These are legible reproductions of the labels and hazard warnings affixed to the device.
Page 36: Symbols And Marking On Package Label
18 Symbols and marking on package label 19 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 37: Distributor And Manufacturer Contact Information
+20° C for 45 minutes, before use and application. 22 Distributor and manufacturer contact information Distributor: SYMBYX Pty Ltd. ABN 29638049073 Suite 2, 50 Yeo Street, Neutral Bay NSW 2089 Australia. Tel +61 (0)2 8066 9966 Email: info@symbyxbiome.com. Website:www.symbyxbiome.com Manufacturer: Spectro Analytic Irradia AB.
Page 38: Electromagnetic Emissions - Guidance And Declaration
25 Electromagnetic emissions – guidance and declaration Guidance and manufacturer’s declaration – electromagnetic emissions The DermaCare 635 nm Laser by SYMBYX is intended for use in the electromagnetic environment specified below. The user of this laser should assure that it is used in such an environment.
Page 39 Guidance and manufacturer’s declaration – electromagnetic immunity The DermaCare 635 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 40: Separation Distances - Portable And Mobile Rf Communications
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 DermaCare 635 nm Medical Laser is used exceeds the applicable RF compliance level above, the DermaCare 635 nm laser should be observed to verify normal operation.
Page 41: Applied Standards
26 Applied standards IEC60601-1:2005:e.d 3.1, IEC60601-1-2:2014, IEC60825-1:2014, IEC60601-1-11:e.d 2, IEC62366:2014, e.d.1.1, IEC60601-1- 6:2013, e.d 3.1, IEC 62304:2006 +A:2015,ANSI/AAMI ES60601-1:2005 and CAN/CSA-C22.2 No 60601-1:08 Other standards in which the device complies with: ISO14971:2012, IEC62304:2006, ISO10993-5, ISO10993-10.