SYMBYX DermaCare 635 User manual

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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After 60 seconds of
treatment the device’s front
light will blink and a sound
will be heard, indicating that
you should move the laser
device to a new treatment
point.
The light indicates
that the laser is
active.
Press against the
skin to activate the
laser.
Press On/Off button to
turn on the device.
The green light indicates
that the device is ready
to use.

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6 Primary operating functions
a) 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.
b) After pressing the push-button switch, the LEDs at the laser apertures are lit repeatably, and several audible signals inform
the operator that the device is ready for use. The device is now in a READY to use state.
c) Place the laser apertures in contact with dry intact skin at the location for treatment.
d) Press gently to start laser emission (start of action).
e) An audible signal indicates the start of laser emission. The laser aperture LED is lit, indicating laser emission.
f) Hold the device in position.
g) An audible and visual information signal informs the operator when a generally optimal laser energy dose per application
point has been delivered.
h) Move the applied part (laser apertures) approximately 1.5 cm.
i) NOTE. During the movement to the next application point (when the device is no longer in contact with skin) the laser
emission stops as well as the light indicators. Audible signals are given to indicate the stop of laser emission.
j) Place in contact and press gently to start emission again, hold in position and wait for the next audio/visual information
signal.
k) Repeat until the entire area on and around the condition or disorder has been covered (i.e. a shoulder, knee, an elbow, etc.).
l) Press and release the push-button switch to turn off and off the device.
m) When the green LED on the push-button no longer is lit (switched off) the device is turned off. Note, failure to turn the device
off, out of standby mode, will result in poor battery duration.
n) Clean the device with disinfectants.
o) Place the device in a safe and dry location (storing).
6.1 Replacement of batteries
See Chapter 7.4.

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7 Treatment controls
7.1 Overview parameters of the treatment protocol for medical recording
Model/ Type
Laser
Wavelength
No. of
laser
diodes
Laser
output
power per
diode
Total
Output
Power
Time
between
each
signal
Emitted laser
energy per diode
between each
signal
Total emitted
energy
between each
signal
Laser
energy
dosage per
diode and
point
DermaCare
Laser by SYMBYX
635 nm
2
50 mW
100 mW
(2 x 50 mW)
60 s
3 J
6 J
3 J/cm²
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.
CAUTION! Be careful when applying the device in contact pressure on elderly people or people with conditions causing them to bruise easily.
8 Medical recording
It is recommended that the personal or medical record contains the following information:
• Date of treatment/s
• Used treatment protocol (i.e. wavelength, output power and Joules per point/cm²).
• Application area (i.e. where the laser radiation has been applied).
• Total treatment time or Joules delivered.
• Patient response to treatment.
9 Device application specification
9.1 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.

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9.2 Expected life before service required
Three to four years.
9.3 Medical purpose/intended use
Intended to reduce pain and inflammation, as well as to promote tissue repair.
9.4 Patient
Human.
9.5 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.
9.6 Application
Contact application on intact skin and skin around orifices.
Caution/warning:Never to be applied on eyes, eyelids or used for treatments through the lens of the eye, including intra-beam
viewing.
9.7 Environment
Indoors, 10 - 90 % atmospheric humidity at temperatures ranging from +5 - 30° C and at air pressure of 700 -1060 hPa.
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.
9.8 Home healthcare environment
Dust, lint and dirt may cause discomfort due to a thermal effect of light absorption in the dirt. Clean lenses before use (Chapter 9.1).

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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.
9.9 Frequency of device use
One to five times a week.
9.10 Treatment/application time per patient (pain & inflammation only)
60 seconds per application point. Total time 5-20 minutes per treatment.
9.11 Treatment interval
Approximately every 48 hours, depending if condition is chronic or acute.
9.12 Number of treatments per patient/sessions per patient
Normally once every 24-72 hours. The treatment interval can be longer, such as once every two to four weeks. Chronic conditions
normally 1 to 3 treatments a week. Acute conditions 3-5 treatments a week.
9.13 Treatment session interval
Continuously.
9.14 Contraindications
Treatment of the eye through the lens; intra-beam viewing.
9.15 Side effects
No known side effects.
9.16 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. Also, with chronic conditions, the patient may experience an increased transitional pain within 48 hours

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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.
IMPORTANT! When treating a patient for the first time a lower dose and treatment time shall be applied for evaluating the reaction of the
treatment. The treatment can cause transient increased pain for some patients and therefore it is recommended that the first treatment
should be limited in dose and time. The manufacturer recommends maximum 30 seconds per treatment point and a maximal treatment time
of 5 minutes for the first treatment.

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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.
f) Nationality: Not relevant.
g) Skin color: Light or slightly pigmented. Absorption of light in dark/black pigmented skin can result in less effective treatments.
Absorption of light in dark/black pigmented skin, hair and tattoos can cause discomfort by heat absorption.
h) Hair color: High power (> 300 mW) may cause discomfort on dark/black hair. See Note 1.
i) Implants, prosthesis, artificial limbs: Not relevant.
j) Reduced sight or blindness: Not relevant.
k) Reduced hearing or deafness: Not relevant.
l) Reduced mobility or paraplegic: Not relevant.
m) Psychological or intellectual disorders and conditions: Caution should be taken when treating patients potentially unable to respond
to pain. See Note 1.
n) Alcohol or tobacco user: Not relevant.
o) Part of body to be treated: The gut/belly or abdomen area, as well as the back of the neck.
p) Body modifications/changes: Tattoos can absorb light and result in less effective treatments. Dark colors can absorb enough light to
cause discomfort. See Note 1.
q) State of the patient: Awake and conscious. The patient should be able to respond to pain. See Note 1.
r) Medications, drugs, anesthetics: Caution should be taken when treating patients on drugs, medications or anesthetics reducing skin
sensitivity or ability to respond to pain. See Note 1.
s) 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. In addition, cosmetic products may also absorb enough light to possibly cause discomfort. See
Note 1.
Note 1) The discomfort a patient may experience is similar to that of a needle prick. Either stop the treatment or constantly move the
device a little between two points. Treatment with the device should always be pain free.

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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. The ordinary operator shall ensure that the patient operator applies the device in accordance with its
intended use and the accompanying documents. The PATIENT becomes the OPERATOR.
ORDINARY operator education and knowledge:
- Medically trained in a relevant profession (physiotherapist, chiropractor, osteopath, nurse, etc.);
- Educated in the use of the device and competent to make a diagnosis;
- Literate;
- Able to follow the instructions for use and the accompanying documents; and
- Understands hygiene and sanitary control procedures.
PATIENT operator education and knowledge:
- Able to follow the instructions and guidance from an ORDINARY operator;
- Literate;
- Able to follow the instructions for use and the accompanying documents; and
- Understands hygiene and sanitary control procedures.
9.19 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.
§ Keep or store the accompanying documents.
§ Make sure the accompanying documents and instructions for use are easily accessible when needed.
§ Make sure that he/she is well acquainted with the device before use.
§ Ensure that the device is used in accordance with its intended use, as well as in accordance with the accompanying
documents (user manual).
§ Be responsible for safe storage and transport of the device.
§ Be responsible for educating, instructing and surveying a PATIENT operator.

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§ 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;
- The operator manages the device with dry or normal hand skin condition or with protective gloves; and
- 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
§ Oils and creams etc. make the grip slippery. The operator might drop the device
9.20 Responsible organization
The responsible organization should designate the responsibility for the device to one person only (the operator). The responsibilities
the responsible organization has include ensuring that the operator of the device is;
- Educated or trained in the use of the device;
- Well acquainted with the device;
- Familiar with the instructions for use and the accompanying documents; and
- Medically or clinically trained to guide a PATIENT operator.
In addition, the responsibilities incorporate;
- Ensuring the supply of proper and correct eye protection wear (if necessary);
- Ensuring means for technical service or support when needed; and
- Using the device in accordance with local laws, regulations and requirements.
9.21 Patient position
The patient should be sitting, standing or lying down. The patient’s skin must not have been in contact with any oils, creams, lotions,
balms, moisturizers, etc. Oils and creams etc. might damage electrical or mechanical components.
Use with caution in the following circumstances!
Treatment should be avoided or performed under supervision and by medical professionals in the following circumstances:
- In or around the neck region in hyperthyroidism;it has not been observed that laser light can cause direct
damage, but since the thyroid is sensitive to light, it is advised to avoid irradiation over the gland, especially with
large doses;
- 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;

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- 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;
- 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. On the other hand, laser therapy can
promote nerve and tissue repair, and such treatments should therefore be performed with correct patient
information and under post treatment surveillance;
- 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; and
- Use of excessive treatment dosages of laser radiation on acute open wounds; it has been observed in rats
subjected to treatment that this has caused temporarily slower healing compared to a control group. Due to the
results from these studies, dosages lower than 15-20 J/cm²are recommended in the treatment of acute open
wounds on both humans and animals.
9.22 Training
Training: Application-specific and operator-orientated instruction or exercises are required for a safe and effective use of the
equipment.
The use and operation of the equipment is assessed to be fairly simple, and the instructions for use (herein) cover all necessary
information concerning the primary operating functions, as well as how to perform successful treatments in accordance with the
INTENDED USE and BASIC SAFETY of the device. In addition, or as a complement to the manual, users of the device can be trained
by the sales/support representative organization, which may also provide advice on the use of the equipment by telephone or via e-
mail.
The responsible organization and the operator are both responsible for ensuring that they have sufficient knowledge and training in
performing treatments with the device. The responsible organization or the operator should contact the manufacturer or its
representative if further education or training is deemed necessary, as well as with questions regarding service.