SYMBYX Biome Laser LED Light Therapy Instruction Manual
- June 1, 2024
- SYMBYX
Table of Contents
Biome Laser LED Light Therapy
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Specifications
- Product Name: DermaCare Laser 635 nm by SYMBYX
- Classification: Class IIa Active Therapeutic Device
- Hand-held Device: Type BF Applied Part, IP22
- Operation: Continuous operation in normal use
- Laser Type: Visible CLASS 3R (model 635)
Product Description
This product is a transportable, hand-held, and internally
powered medical electrical equipment that administers visible Class
3R laser radiation to a patient. It is a non-invasive Class IIa
active therapeutic device. The device is classified as a Type BF
applied part and has an IP22 rating. It is designed for continuous
operation during normal use.
Usage Instructions
Warnings and Precautions
1. Keep portable RF communications equipment at least 30 cm away
from the device to prevent performance degradation.
2. Ensure compliance with national regulations for laser use and
personal protective equipment.
Operation
1. Turn on the device using the ON/OFF control.
2. Administer the laser therapy to the patient according to the
prescribed guidelines.
Maintenance
1. Store the device in a safe and dry place when not in use.
2. Handle the device with care to prevent damage to the laser
components.
FAQ
Q: Can the device be used continuously?
A: Yes, the device is classified for continuous operation during
normal use.
Q: Are there any user restrictions?
A: User restrictions may apply, refer to the user manual for
specific details.
Q: Can modifications be made to the equipment?
A: No modifications are allowed as they may compromise basic
safety.
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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 10
Press On/Off button to turn on the device. The green light indicates that the device is ready to use.
The red light indicates that the laser is active.
Press against the skin to activate the laser.
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.
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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
DermaCare
635 nm
2
50 mW
100 mW
60 s
3 J
Laser by SYMBYX
(2 x 50 mW)
Total emitted energy
between each signal
6 J
Laser energy dosage per diode and point
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 selftreatment. 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/cm² are 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 email.
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.
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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. the push-button switch is turned off and the green LED is not lit. To
safely replace or remove the batteries follow the instructions described in
this manual. The operator must not touch the patient while removing or
replacing the batteries, unless the patient is the operator.
10.1 Battery safety
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. The operator should contact the supplier or manufacturer
for support or service in every case where there are changes in the
performance of the device, or if one suspects any faults.
10.2 Warnings and precautions
§ Do not use or store the battery or the device at high temperatures, e.g. in
strong direct sunlight, in cars during hot weather, or directly in front or on
top of heaters. This may cause battery fluid leakage, impaired performance,
and a shortening of the battery service life.
§ Do not splash any liquids on the device or allow the battery terminals to
become damp. This may cause heat generation and formation of corrosion on the
battery and its terminals, which in turn may cause electrical shocks, battery
fluid leakage, explosion or fire.
§ Do not use or store the device in locations with a high atmospheric
humidity. This may cause heat generation and formation of corrosion on the
battery and its terminals, which in turn may cause electrical shocks, battery
fluid leakage, explosion or fire.
§ Keep the device and batteries out of the reach of children. Avoid situations
where children may chew on or lick the batteries or device.
§ Do not dispose of the device or the batteries in fire or heat. Doing so can
melt the insulation and damage sealed parts or protective safeguards, cause
battery fluid leakage, explosion or fire.
§ Do not strike or throw the device containing batteries. The impact may cause
battery fluid leakage, explosion or fire.
21
§ 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. Leaked electrolyte
can damage the eyes and lead to permanent loss of eyesight.
§ If skin or clothing comes in contact with leaked electrolyte, wash the
affected area immediately with clean water. Leaked electrolyte can cause skin
damage.
§ The device and the batteries should be disposed of in a proper and
environmentally safe way. Batteries that are no longer usable should be
returned to the manufacturer or sent to a company specialized in the disposal
of hazardous electrical materials and batteries.
§ Do not open or dissemble the device or parts other than what is intended for
removal or replacement of batteries. Doing so may cause short circuit, battery
fluid leakage, heat generation, explosion or fire.
10.3 Recycling of batteries
The batteries should be disposed of in a proper and environmentally safe way.
Batteries that are no longer usable should be returned to the manufacturer or
sent to a company specialized in the disposal of hazardous electrical
materials and batteries.
22
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.
Remove the battery cover
Switch off the device with push button. (Green LED off)
23
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. See Chapter 21 for instructions for
packaging and transporting.
24
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. wavelength range and optical
density OD+); – Information and warnings regarding direct intra-beam viewing
and non-diffuse reflections; – Appropriate maintenance instructions; and –
Clear warnings and classifications.
Human access is necessary for the performance of the function(s) of the
product. During its intended use, the patient is exposed to laser radiation;
however, eye exposure must always be avoided. Dark, tattooed, or highly
pigmented skin may absorb laser radiation and cause thermal heating and
discomfort. The instructions herein describe how to use the device safely on
such skin conditions. The instructions for use have been compiled and
evaluated in accordance with usability safety standard IEC60601-1-6.
The laser emission from the device has been calibrated, tested and measured
before product release. The actual laser output measured in the working area
does not deviate from the set value by more than ±20 %. An increase or a
decrease of emission can occur due to the following reasons:
– An increased temperature of the laser/laser chip; may decrease the emission
by 10 – 20 %; – Broken protection lenses; may increase the emission by 5 %; –
Excessive increased temperature due to component failure, resulting in a
change of the component characteristics; either no
change or an increased or a decreased emission by 10 – 20 %; – Component
failure; decreases the emission, or results in no emission at all (broken
circuit); and – Dirty laser apertures (protective lenses); decreases the
emission.
The equipment should be protected against unauthorized use, for example by
storing the device at a controlled and inaccessible location and permanently
turned off.
The device is equipped with a stand-by/ready function. The device enters
stand-by when the push-button switch is pressed to “ON” position. In the “ON”
position, the green LED on the push-button switch is activated. The transition
to “ready” is clearly indicated by repeated audible signals and the flashing
of the LEDs at the laser aperture. The transition from stand-by to ready takes
about 2.5 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.
25
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.
11.2 General risks with Class 3R Lasers according to IEC 60825-1. See Chapter
2.2 of this manual
11.3 Maintenance and control of emitted output power
Operating this device with an output power that is much lower than intended or
what has been specified may result in poor or ineffective treatments. If the
output power is much higher (+50 %) the NOHD is increased. If the operator
wants to check the output power, the operator should send the device to the
supplier of the device or some other source in order to make certain that the
device operates within specifications. If the output power deviates by more
than ± 20 %, contact the supplier or the manufacturer for technical service
and calibration of the device. The laser should be measured in those cases
where a patient experiences discomfort under recommended use conditions. For
further questions, considerations or need of technical service, please contact
the supplier or the manufacturer.
Important notes regarding periodic measurements of the output power: The power
meter must be able to:
– Measure the wavelengths that the laser emits; and – 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 very close to the laser
aperture to ensure that the whole beam is fitted onto the part measuring the
output power; and – Measurements should be performed on all apertures.
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.
“CAUTION: Use of controls or adjustments or performances of procedures other
than those specified herein may result in hazardous situations.” The intent of
the warning is to inform the operator that BASIC SAFETY may be compromised by
not using the device in its normal condition and in accordance with normal
practice and intended use.
26
“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. Personal protective equipment (optional requirement)
If the responsible organization/operator or home patient wants to use
protective eye safety wear the recommendations for protective eye wear are as
follows:
– 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 0.05 W laser is
reduced to 0.05 mW by using protective eyewear with OD+3 – The eye safety wear
shall protect the wavelength the laser emits Example of protective eyewear for
a 904 nm 0.03 W laser. Wavelength range = 880 – 920 nm
NOTE: Many countries have regulations and standards for personal protective
wear/equipment. Contact the appropriate national agency for those
requirements.
12 General electrical and mechanical safety
12.1 Cleaning/disinfection procedures
The device is not intended to be sterilized. The equipment is intended for
direct physical contact with the patient on clean and dry skin (normal skin
conditions). Cleaning/disinfection should be performed before use. The
operator is advised to clean the equipment with 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. Do not place the device under running water, splash
solvents, or use soaked towels or cotton pads when cleaning the device. Liquid
entering the device may damage electrical circuits or cause damage to the
batteries, resulting in short-circuit, laser emission failure, battery fluid
leakage, heat generation etc. Dirty lenses or lenses containing a crack may
absorb laser radiation, thereby creating a tiny heated spot on the lens. This
may, when the aperture is placed in contact with the skin, cause discomfort to
the patient. Patients may experience a sensation similar to that of a slight
needle prick.
27
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:
No. Inspection
Potential problem
Action to be taken
1
Inspection of the housing
Damaged mechanical parts or a deformed shape, such as Do not use the device. The battery may be damaged.
(overview of the device)
dents, may indicate that the device is no longer functioning Contact the distributor or manufacturer for technical
normally. A deformed enclosure may be uncomfortable for service and replacement of part
the patient and could, in worst cases, cause skin breakage
or small cut wounds
2
Laser aperture protective lenses Damaged lenses may cause cut wounds. Cleaning or
Do not use or clean the device.
using the device in this condition may cause electrical
Contact the distributor or manufacturer for technical
component failure
service and replacement of part
3
Loose or lost screws
Loose or lost screws may cause the housing of the device Reattach the screws. Contact the distributor or
to come apart
manufacturer for technical service and replacement of
lost screws
4
Legible labels and markings
If symbols, text markings or labels have deteriorated, their Contact the distributor or manufacturer for technical
meaning could be misunderstood. This might increase any service and replacement of signs, labels and markings
potential usage risks
5
Green LED is lit when the push If not lit; failure of switch or LED. Batteries may be
Check the positioning of batteries. Contact the
button is pressed ON (ready
replaced in wrong direction
distributor or manufacturer for technical service and
state)
replacement of part
6
Laser aperture LEDs are lit when If not lit; the laser diode may not emit laser radiation, or
Control the output power with a power meter. Contact
the laser is activated
the aperture LED is broken and does not indicate when
the distributor or manufacturer for technical service
the laser is emitting radiation
and replacement of part
12.3 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. The service manual includes:
– Clear warnings and precautions to be taken to avoid possible exposure to
laser radiation above Class 1 and similar hazards; – A list of controls and
procedures, implementable by persons other than the manufacturer or his or her
agents, which
increase the accessible emission levels of radiation; – Clear warnings and
precautions to be taken to avoid exposure to possible battery failure and
similar hazards;
28
– 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. All parts will be supplied by the
manufacturer to ensure that correct components are used
by the service personnel.
13 Description of controls, messages, and indicators
13.1 Laser emission
control
When pressed into contact with surface (the skin), the laser diodes are
activated and starts to emit laser radiation through the laser aperture. A
single audible signal indicates “start of action” and laser emission. A laser
aperture LED is illuminated to indicate emission of laser radiation
When lifted or moved from the surface contact (skin) the laser diodes stop
emitting laser radiation through the laser aperture. Double audible signals
indicate “stop of action”, and thus stop of laser emission. When laser
radiation is stopped, the laser aperture LED is switched off
NOTE. If, by any reason, the laser emission is not stopped when the laser
apertures are not in contact with the surface/skin, the operator can use the
push-button on the rear end of the device to cut the power to the laser diodes
and thereby stop the emission of laser radiation immediately
13.2 ON/OFF
Switch the device “ON” or “OFF”. To indicate connection or disconnection. Each position, “ON” or “OFF”, is a stable position. When the Green LED is switched on, the device is turned “ON”
29
14 Technical specifications (general)
Product Type Device type Model Electrical classification Laser class IP
classification Battery type Internal power source Current consumption Working
voltage Typical power consumption Battery time (before need of change to new
batteries) Materials (enclosure) Notified body nr. CE-mark
Medical electrical equipment Therapeutic laser/medical laser Non-invasive
active therapeutic DermaCare 635 Type BF 3R IP22 LR03 AAA 1.5 V non-
rechargeable 6 pcs primary LR03 AAA 1.5 V battery < 0.35 A 6 – 9 VDC < 3 W
Approximately 2.5 hours Powder painted aluminum. Plastic enclosure CE 0413
The product is CE marked in accordance to the requirements of MDD 93/42/EEC.
30
15 Technical specifications
15.1 DermaCare Laser 635 nm by SYMBYX
Laser type Wavelength(s) Type of radiation Beam type Beam divergence Spot size (at contact application) Continuous or pulsed laser Pulse frequency Pulse duration Maximum average aperture output power (per laser diode) Maximum aperture peak power output Number of laser diodes Total average output power Aperture size NOHD (3R exposure) Protective eyewear MPE level at skin contact (W/m²) Laser class
AlGaInP 635 nm ± 5 nm Red, visible Divergent 8,5×33 grader (FWHM) or ~ 0,57 rad 9 mm in diameter (63,5 mm²) Pulsed 250 Hz 440 µs 50 mW ± maximum 20% 450 mW 2 100 mW Ø 0,9 cm < 0,4 m Minimum OD+3 at 635 nm ± 20 nm 0,05W/63,5 mm² = 0,000787 W/mm² = 787 W/m² 3R
31
16 Definitions
Terms Non-invasive treatment
Laser aperture Laser diode Laser light Laser radiation Treatment point Point
size Application point Treatment area Contact pressure treatment Output power
mW Joule
Dose
LASER LED
Description 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 The opening from which laser radiation is emitted The
component that produces and emits laser radiation Laser radiation that is
visible, i.e. that has a wavelength within the visible range of wavelengths
Laser radiation that is invisible, i.e. that has a wavelength outside the
visible range of wavelengths The point where the laser aperture is applied and
on which treatment is performed (~1 cm² per aperture) The size within which
the laser beam is applied (~1 cm² per aperture) Each place where the operator
applies the device or laser The area on and around the pain area of body The
apertures are placed in contact pressure with a force of approximately 1 – 5
Newtons
The light intensity of the laser radiation, or the laser’s “power” milliwatt.
1 mW = 0.001 W. The output power is measured in mW The energy of laser
radiation delivered. The laser radiation is measured by the intensity of light
(mW) multiplied by the time (seconds). J = mW x s The quantity of laser
radiation energy applied to a certain area. Commonly measured in joules
delivered per cm² (J/cm²) Laser is an acronym for Light Amplification by
Stimulated Emission of Radiation LED is an acronym for Light Emitting Diode
(used as indicators)
32
Terms Accompanying documents Active therapeutic device
Applied part
Basic safety
Essential performance Hand-held Hazard
Intended use
Internally powered Normal condition Normal use Operator Patient Responsible
organization
Risk Service personnel
Tool Transient
Description Documents and information for the responsible organization or operator regarding the medical electrical equipment, particularly about basic safety and essential performance The operation of the device depends on an electrical energy source, and is used for the treatment or alleviation of injuries and diseases The part of the medical electrical equipment that in normal use comes into physical contact with the patient during treatment Freedom from unacceptable risks directly caused by physical hazards when the medical electrical equipment is used under normal conditions and in single fault condition Performance necessary to achieve freedom from unacceptable risks Term referring to electrical equipment that is intended to be managed by hand in normal use Potential source of harm (harm is defined as physical injury or damage to the health of people or animals, as well as damage to property or the environment) Use of a product, process or service in accordance with the specifications, instructions and information provided by the manufacturer Term referring to electrical equipment that is able to operate by means of an internal electrical power source Condition in which all provided means to prevent hazards are intact Operation and use, including routine inspections and adjustments, in accordance with the instruction manual Person handling the equipment Person undergoing treatment Entity accountable for the use and maintenance of a medical electrical equipment or system. For example, a hospital, an individual clinician or a layperson. For domestic use, the patient, operator and responsible organization can be one and the same person Combination of the degree or probability of harm and the severity of the harm caused Persons accountable to the responsible organization for installing, assembling, maintaining, and repairing the medical electrical equipment An instrument that can be used manually to secure or release fasteners/screws or to make adjustments Normally intended for less than 60 minutes of continuous use
33
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. start of laser
emission (press aperture against surface) Stop (of action) To identify the
control by means of which an action is stopped, i.e. stop of laser emission
(remove aperture from surface)
Type BF applied part
Follow instructions for use. Consult the accompanying documents before use or action
General symbol for recovery/recycling Indicating that the material can be part of a recovery/recycling process
The WEEE symbol Indicating a separate collection for WEEE products, i.e. waste electrical and electronic equipment
IP22
ENCLOSURES of ME EQUIPMENT and ME SYSTEMS designed to give a specified degree of protection against harmful ingress of water or particulate matter. IP22 means protection against vertically falling water drops when
tilted 15° and objects 12.5 mm Ø and greater
NOTE. Reference for symbols. IEC60825-1:2014, IEC60601-1:2005 and IEC60878:2003
34
17.1 Labels on the device
These are legible reproductions of the labels and hazard warnings affixed to
the device.
35
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:
· Use of the device that is not in accordance with its normal or intended use.
· Neglected maintenance and failure to take appropriate actions when cleaning,
storing, transporting or using the device. · Failure to follow the
instructions in the accompanying documents. · Use of the device that is not in
accordance with laws, regulations or requirements.
20 Disposal and recycling of the device
The device should be disposed of in a proper and environmentally safe way. The
device and batteries that are no longer usable should be sent back to the
manufacturer for proper disposal or to a company specialized in the disposal
of hazardous electrical materials and batteries. Electrical components, PC-
boards should be sorted as electrical component disposal. The aluminum housing
can be recycled or sorted into metal aluminum disposal. The laser diodes
should be sorted as hazardous electrical components, or together with lamps,
LEDs, etc.
21 Transport and packaging of the device
Save and use the original package which the device was delivered in for
transport and storage. During transport or storage, the device should be
switched off. The device should be stored/transported within the temperature
range of -25 to + 70 C, 5 – 95 % humidity and 540 – 1,060 hPa air pressure and
placed in a dry package that protects the device from vibrations, impacts and
shock. If the original package has been lost, the device should be packaged in
a carton box with impact/vibration reducing materials such as air caps,
36
towels or crumpled paper. Do not use the device if has been stored or
transported at its minimum or maximum storage temperature. If stored or
transported at -25 or 70° C let the device cool down or heat up, to reach its
intended temperature range for use, in ambient room temperature of +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.
Fagerstagatan 9, 163 53 Spånga, Sweden Phone: +46-8-7672700, www.irradia.se.
For all technical service and support, please contact the Distributor.
23 Reporting serious incidents
Any serious incident that has occurred in relation to the device should be
reported by the user and/or patient to the manufacturer and the competent
authority of the Member State/Country in which the user and/or patient is
established.
24 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, is 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. Electromagnetic Immunity
Standards are used to ensure that the Medical Electrical Equipment performs
satisfactorily within its intended environment. The electromagnetic
disturbance environment can occur in the shape of ambient temperature,
humidity, and atmospheric pressure. Medical Electrical Equipment and Systems
may experience environmental conditions within the expected range of the
interference environment at any time, and for extended periods of time,
without the operator being aware of the ambient levels on a continuous basis.
It is the manufacturer’s responsibility to design the product according to the
necessary requirements, as well as to provide the Operator or Responsible
Organization with information for creating and maintaining a compatible
electrical environment so that the Medical Electrical Equipment or System can
perform as intended.
List of ACCESSORIES with which compliance is met: None, no accessories.
37
The use of ACCESSORIES, transducers and cables other than those specified herein, or those sold by the manufacturer as replacement parts for internal components, may result in increased EMISSION or decreased IMMUNITY of the ME EQUIPMENT.
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.
Emissions test
RF emissions CISPR 11
Compliance Class B
Electromagnetic Environment – guidance
The DermaCare 635 nm Laser by SYMBYX is suitable for use in all establishments
including domestic establishments and those directly connected to the public
low-voltage power supply network that supplies buildings used for domestic
purposes.
25.1 Electromagnetic immunity guidance and declaration
Immunity test
IEC 60601 test level
Compliance level
Electrostatic discharge (ESD) IEC 61000-4-2
±8 kV contact ±15 kV air
±8kV contact ±15 kV air
Power frequency (50/60 Hz) magnetic field IEC 61000-4-8
3 A/m
30 A/m
Electromagnetic environment – guidance
Floors should be wood, concrete or ceramic tile. If floors are covered with
synthetic material, the relative humidity should be at least 30 %
Power frequency magnetic fields should be at levels characteristic of a
typical location in a typical commercial or hospital environment
38
NOTE: UT is the a.c. mains voltage prior to application of the test level.
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.
Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment – guidance
Portable and mobile RF communications equipment should be used no closer to any part of the DermaCare 635 nm, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter
Recommended separation distance
d = 1,2 P
Radiated RF IEC 61000-4-3
10 V/m (Home Healthcare environment)
Immunity to RF wireless communication equipment (Table 9) 385-5800 MHz 9-28
V/m
10 V/m (Home Healthcare environment)
Immunity to RF wireless communication equipment (Table 9) 385-5800 MHz 9-28
V/m
d = 1,2 P 80 MHz to 800 MHz d = 2,3 P 800 MHz to 2.5 GHz
where P is the maximum output power rating of the transmitter in watts (W)
according to the transmitter manufacturer and d is the recommended separation
distance in meters (m)
Field strengths from fixed RF transmitters, as determined by an
electromagnetic site survey, a should be less than the compliance level in
each frequency range b
Interference may occur in the vicinity of equipment marked with the following
symbol
NOTE 1: At 80MHz and 800MHz, the higher frequency range applies. NOTE 2:
Guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflected from structures, objects and people.
39
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. 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. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the DermaCare 635 nm Laser by SYMBYX. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.
25.2 Separation distances portable and mobile RF communications
Recommended separation distances between portable and mobile RF communications equipment and the DermaCare 635
nm Laser by SYMBYX
The DermaCare 635 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.
Rated maximum output
Separation distance according to frequency of transmitter
power of transmitter
m
W
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2.5 GHz
d = 1,2 P
d = 1,2 P
d = 2,3 P
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be
estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.
Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects and people.
40
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, IEC60601-16:2013, 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.
41