SYMBYX DermaCare 635 Manuel utilisateur
INSTRUCTION MANUAL
DermaCare 635 nm Laser by SYMBYX
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CONTENTS
1 General information............................................................................................................................7
2 Product description ............................................................................................................................7
3 Separate power supply source (mains supply transformer)...............................................................8
4 Essential performance and basic safety ............................................................................................8
4.1 Temperature range for use .................................................................................................................... 8
4.2 User restrictions ...................................................................................................................................... 8
4.3 General caution and warning statements ............................................................................................ 8
5 Device description and use ................................................................................................................8
5.1 Operation description of laser treatment (general) ............................................................................ 9
5.2 General risks and hazards with class 3R lasers (IEC60825-1:2014) .............................................. 9
5.3 Device overview .................................................................................................................................... 10
6 Primary operating functions .............................................................................................................12
6.1 Replacement of batteries ..................................................................................................................... 12
7 Treatment controls ...........................................................................................................................13
7.1 Overview parameters of the treatment protocol for medical recording ......................................... 13
8 Medical recording .............................................................................................................................13
9 Device application specification .......................................................................................................13
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9.1 Description ............................................................................................................................................. 13
9.2 Expected life before service required ................................................................................................. 14
9.3 Medical purpose/intended use ............................................................................................................ 14
9.4 Patient ..................................................................................................................................................... 14
9.5 Operator ................................................................................................................................................. 14
9.6 Application ............................................................................................................................................. 14
9.7 Environment ........................................................................................................................................... 14
9.8 Home healthcare environment ............................................................................................................ 14
9.9 Frequency of device use ...................................................................................................................... 15
9.10 Treatment/application time per patient (pain & inflammation only) ........................................... 15
60 seconds per application point. Total time 5-20 minutes per treatment. ............................................... 15
9.11 Treatment interval ............................................................................................................................. 15
9.12 Number of treatments per patient/sessions per patient .............................................................. 15
9.13 Treatment session interval .............................................................................................................. 15
9.14 Contraindications .............................................................................................................................. 15
9.15 Side effects ........................................................................................................................................ 15
9.16 Patient potential reaction ................................................................................................................. 15
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9.17 Patient population ............................................................................................................................. 17
9.18 Intended OPERATOR ...................................................................................................................... 18
9.19 Operator responsibilities .................................................................................................................. 18
9.20 Responsible organization ................................................................................................................ 19
9.21 Patient position .................................................................................................................................. 19
9.22 Training ............................................................................................................................................... 20
10 General battery safety information ...................................................................................................21
10.1 Battery safety ..................................................................................................................................... 21
10.2 Warnings and precautions ............................................................................................................... 21
10.3 Recycling of batteries ....................................................................................................................... 22
10.4 Replacement of batteries ................................................................................................................. 23
10.5 Transport and storage of the device .............................................................................................. 24
11 Laser safety......................................................................................................................................25
11.1 General laser safety information ..................................................................................................... 25
11.2 General risks with Class 3R Lasers according to IEC 60825-1. See Chapter 2.2 of this
manual 26
11.3 Maintenance and control of emitted output power ....................................................................... 26
11.4 Protective eyewear. Personal protective equipment (optional requirement) ............................ 27
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12 General electrical and mechanical safety ........................................................................................27
12.1 Cleaning/disinfection procedures ................................................................................................... 27
12.2 Visual inspections ............................................................................................................................. 28
12.3 Information for service technicians ................................................................................................. 28
13 Description of controls, messages, and indicators...........................................................................29
13.1 Laser emission control ..................................................................................................................... 29
13.2 ON/OFF .............................................................................................................................................. 29
14 Technical specifications (general)....................................................................................................30
15 Technical specifications ...................................................................................................................31
15.1 DermaCare Laser 635 nm by SYMBYX ........................................................................................ 31
16 Definitions ........................................................................................................................................32
17 Labels and symbols .........................................................................................................................34
17.1 Labels on the device ......................................................................................................................... 35
18 Symbols and marking on package label ..........................................................................................36
19 Limitation of liability ..........................................................................................................................36
20 Disposal and recycling of the device................................................................................................36
21 Transport and packaging of the device ............................................................................................36
22 Distributor and manufacturer contact information ............................................................................37
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23 Reporting serious incidents..............................................................................................................37
24 Electromagnetic compatibility (EMC) ...............................................................................................37
25 Electromagnetic emissions – guidance and declaration ..................................................................38
25.1 Electromagnetic immunity – guidance and declaration ............................................................... 38
25.2 Separation distances – portable and mobile RF communications ............................................. 40
26 Applied standards ............................................................................................................................41
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1 General information
This operating and user manual applies to the DermaCare 635 nm Laser by SYMBYX. This laser device is manufactured for SYMBYX
Pty Ltd of Australia by Spectro Analytic Irradia AB of Sweden. Please read this manual before using the product. The reader is
advised to keep the manual at hand for future reference when necessary. MEDICAL ELECTRICAL EQUIPMENT requires special
precautions regarding EMC and need to be installed and put into service according to the EMC information provided in the
ACCOMPANYING DOCUMENTS. Portable and mobile RF communication equipment can affect MEDICAL ELECTRICAL
EQUIPMENT.
“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. Otherwise, degradation of the performance of this equipment could result.”
The use of accessories, cables, and transducers other than those specified herein as replacement parts for internal components, with
the exemption of transducers and cables sold by the manufacturer of the EQUIPMENT, may result in increased EMISSIONS or
decreased IMMUNITY of the EQUIPMENT. The EQUIPMENT should not be used adjacent to, or stacked on top of, other equipment.
If it is necessary to use the EQUIPMENT under those circumstances, the EQUIPMENT should be continuously observed in order to
verify normal operation in the configuration in which it is used. The RESPONSIBLE ORGANIZATIONS are advised to carry out all
adjustments and cleaning and disinfection PROCEDURES as specified herein. The RESPONSIBLE ORGANIZATIONS are reminded
that the assembly of ME SYSTEMS, as well as modifications during the actual service life, is evaluated as regards to the requirements
of IEC60601-1.
Many countries have regulations, laws, requirements, and standards for personal protective equipment and the installation and use of
lasers, including their clinical use. Contact the appropriate national agency for the correct user requirements.
2 Product description
This product is a TRANSPORTABLE, HAND-HELD and INTERNALLY POWERED MEDICAL ELECTRICAL EQUIPMENT that is a
NON-INVASIVE CLASS IIa ACTIVE THERAPEUTIC DEVICE, with which the OPERATOR administers Visible CLASS 3R (model
635) LASER radiation to a PATIENT. The HAND-HELD device is classified as a TYPE BF APPLIED PART, and IP22. The equipment
is classified for CONTINUOUS OPERATION in NORMAL USE.
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3 Separate power supply source (mains supply transformer)
Not used.
4 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.
4.1 Temperature range for use
Discharge of batteries: 10 - 90 % atmospheric humidity at temperatures ranging from +5 - 30° C and air pressure of 700 - 1060 hPa.
4.2 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
safety precautions and instructions for use may lead to a potentially dangerous exposure of the eyes (by intra-beam viewing at close
range). To prevent these situations from occurring, as well as to ensure safe use of the device, the safety precautions mentioned in
this manual should be strictly observed.
4.3 General caution and warning statements
“WARNING: The use of controls, adjustments to the device, or performance of procedures other than those specified herein
may result in hazardous situations.” This warning intends to inform the operator that BASIC SAFETY may be compromised by not
using the device in its normal condition and in accordance with its normal use and intended use.
“WARNING!No modification of this equipment is allowed.” This statement addresses the HAZARDS that can follow 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.
5 Device description and use
This device is a transportable, hand-held, continuous-pulsed, red light, battery-operated medical laser product, with which the operator
administers non-invasive laser radiation to promote tissue repair. This device is intended to be used as a supplementary treatment
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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.
5.1 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. An audible and
visible signal informs the operator when to switch application point. At each signal, the laser aperture is moved approximately 1.5 cm
until the whole condition area has been covered. Treatment shall only be performed onto and in contact with intact normal skin and
skin conditions.
WARNING! Do NOT use the device in contact with sensitive and broken skin or open wounds. Do NOT use the device in
contact with eyelids. Do NOT view the divergent beam with magnifiers.
5.2 General risks and hazards with class 3R lasers (IEC60825-1:2014)
Laser products that emit radiation that exceed the MPE under direct intra-beam viewing, the risk of injury in most cases is relative low.
Class 3R laser products are not considered intrinsically unsafe, the risk is limited because unintentional exposures would rarely reflect
worst-case conditions (beam alignment, large pupil with entire beam energy entering the eye, as well as the safety margin in the MPE,
and the natural aversion behavior for exposure to bright light of visible radiation and by response to heating of the cornea for far
infrared radiation). The risk of injury increases with exposure duration, and exposure may be hazardous for ocular exposure under
worst-case conditions or for intentional direct intra-beam viewing.
Dazzle, flash-blindness and afterimages may be caused by a beam from a Class 3R laser product in the visible wavelength range,
particularly under low ambient light conditions. This may have indirect general safety implications resulting from temporary
disturbance of vision or from startle reactions. Such visual disturbances could be of particular concern if experienced while performing
safety-critical operations such as working with machines or at height, with high voltages or driving. Class 3R lasers should only be
used where direct intra-beam viewing is unlikely.
Blue light lasers can cause photochemical injuries to the eye if one looks at the light for a prolonged period of time. Lasers with
wavelengths close to the UV-spectrum (400 nm) should be used with caution on patients that are light sensitive or who are using
herbs or drugs causing sensitivity to light. Pulsed visible laser light with a pulse frequency up to 60Hz may trigger photosensitive
epilepsy.
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5.3 Device overview
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