SYMBYX BIOME ProSeries User manual

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Instruction Manual
ProSeries

INSTRUCTION MANUAL FOR PROSERIES MEDICAL LASER
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Contents
Table of Contents
1. GENERAL INFORMATION 7
1.1 Product Description 7
1.1.1 Accessories 8
1.2 Separate Power Supply Source (Mains Supply Transformer) 8
1.3 Essential Performance And Basic Safety 8
1.4 Temperature Range For Use Indoors 8
1.5 User Restrictions 9
1.6 General Caution And Warning Statements 9
1.7 Licensing 9
2. DEVICE DESCRIPTION AND USE 10
2.1 Device Design 10
2.2 Operation Description of Laser Treatment (General) 11
2.3 General Risks and Hazards with Class 3B Lasers 11
2.4 Device Overview Base Unit / Table-Top Unit 12
2.5 Device Overview Hand-Held Units (Laser Probe) 13
3. PRIMARY OPERATING FUNCTIONS 14
3.1 Charging of The Battery 15

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4. TREATMENT CONTROLS 17
4.1 Overview Chart of The Treatment Controls 17
4.2 Treatment Application 10
5. TREATMENT ADJUSTMENTS 21
5.1 Skin Phototypes, Hair Colours 21
5.2 Skin Types, Body Modications, Tattoo Colours 21
5.3 Body Constitution 22
6. MEDICAL RECORDINGS 24
7. DEVICE APPLICATION SPECIFICATION 25
7.1 Description 25
7.1.1 Expected Service Life 25
7.2 Medical Purpose / Intended Use 25
7.3 Patients 25
7.4 Operator 25
7.5 Application 26
7.6 Environment 26
7.7 Frequency of Device Use 26
7.8 Treatment/Application Time Per Patient 26
7.9 Treatment Interval 26
7.10 Number of Treatments / Sessions Per Patient 27
7.11 Treatment Session Interval 27

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7.12 Contraindications 27
7.13 Side Effects 27
7.14 Patient Reaction 27
7.15 Patient Population 28
7.16 Intended Operator 29
7.17 Operator Responsibilities 30
7.18 Responsible Organization 30
7.19 Patient Position 31
7.20 Training 32
8. GENERAL BATTERY SAFETY INFORMATION 33
8.1 Battery Safety 34
8.2 Warnings and Precautions 34
8.3 Recycling of Batteries 35
8.4 Replacement of Battery 36
8.5 Transport and Packaging of The Device for Change of Battery 36
9. LASER SAFETY 37
9.1 General Laser Safety Information 37
9.2 General Risks with Class 3B Lasers According to IEC 60825-1 38
9.3 Maintenance and Control of Emitted Output Power 38
9.3.1 The Power Meter / Power Tester 40
9.4 Protective Eyewear. Personal Protective Equipment 40

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10. GENERAL ELECTRICAL AND MECHANICAL SAFETY 41
10.1 Cleaning / Disinfection Procedures 41
10.2 Visual Inspections 41
10.3 Information for Service Technicians 43
11. DESCRIPTION OF CONTROLS, MESSAGES AND INDICATORS 44
11.1 LCD-display 44
11.2 Treatment control 44
11.3 Treatment control 44
11.4 Treatment control 44
11.5 Treatment control 45
11.6 Joule Set control button 45
11.7 Time Set control button 45
11.8 Frequency Set control button 45
11.9 Battery status indicator 46
11.10 Step-Up / Step-Down 46
11.11 Reset 46
11.12 INTERLOCK 46
12. TECHNICAL SPECIFICATIONS (GENERAL) 47

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13. TECHNICAL SPECIFICATIONS (LASER) 49
13.1 Laser Diode for Laser Probe 904 nm 49
13.2 Laser Diode for Laser Probe 635 nm 100mW 50
13.3 Laser Diode for Laser Probe 635 nm 400 mW 51
13.4 Laser Diode for Laser Probe 808 nm 52
14. DEFINITIONS 53
15. LABELS AND SYMBOLS 56
15.1 Labels and Markings on The Product 58
15.2 Symbols and Marking on Package Label 59
16. LIMITATION OF LIABILITY 60
17. DISPOSAL AND RECYCLING OF THE DEVICE 61
18. TRANSPORT AND PACKAGING OF THE DEVICE AND / OR BATTERY HOUSING 62
19. MANUFACTURER CONTACT INFORMATION 63
19.1 Reporting Serious Incidents 63
20. ELECTROMAGNETIC COMPATIBILITY (EMC) 64
20.1 Electromagnetic Emissions – Guidance and Declaration 64
20.2 Electromagnetic Immunity – Guidance and Declaration 65
20.3 Separation Distances – Portable and Mobile RF Communications 68
21. APPLIED STANDARDS 70

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1. GENERAL INFORMATION
This instruction manual applies to the ProSeries Medical Laser by SYMBYX. This laser device is manufactured by Spectro Analytic
Irradia AB of Sweden and is the result of a product collaboration between the two companies. (Note: Irradia also manufacture an
identical product called the MID 2.5 Laser). Please read this manual before using the product and keep the manual at hand for
future reference when necessary. MEDICAL ELECTRICAL EQUIPMENT requires special precautions regarding EMC and needs 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 this device, including cables specied by the manufacturer. Otherwise,
degradation of the performance of this equipment could result.”
The use of accessories, cables, and transducers other than those specied 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 conguration in which it is used. The RESPONSIBLE ORGANIZATIONS are advised to carry out
all adjustments and cleaning and disinfection PROCEDURES as specied herein. The RESPONSIBLE ORGANIZATIONS are
reminded that the assembly of ME SYSTEMS, as well as modications 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.
1.1 Product Description
This product is a TRANSPORTABLE INTERNALLY POWERED MEDICAL ELECTRICAL EQUIPMENT that is a NON-INVASIVE
CLASS IIIb ACTIVE THERAPEUTIC DEVICE, with which the OPERATOR administers TRANSIENT PULSED CLASS 3B
INFRARED A (IRA) or visible LASER radiation to a PATIENT. The equipment consists of two parts, the INTERNALLY POWERED
Base Unit and the HAND-HELD devices which emits LASER light through the APPLIED PART (or laser APERTURE), and the
Lithium-Ion battery charger which can charge and power the device through the MAINS SUPPLY. The HAND-HELD device is
classied as a TYPE B APPLIED PART and is considered to be a CLASS II electrical equipment when connected to the MAINS

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SUPPLY through the Lithium-Ion battery charger, and INTERNALLY POWERED when not. The MAXIMUM MAINS VOLTAGE
is 250 V.
The ENCLOSURE of the MAINS SUPPLY TRANSFORMER and the HAND-HELD device are classied as IP20. The equipment
is classied for CONTINUOUS OPERATION in NORMAL USE. The SECONDARY CIRCUIT of the equipment, i.e., its INTERNAL
POWER SOURCE, is only RATED suitable for connections to the MAINS SUPPLY at primary voltages of 100-240 VAC ± 10%
by using the accompanying Lithium-Ion battery charger. The INTERNAL POWER SOURCE is a COMPONENT WITH HIGH-
INTEGRITY CHARACTERISTICS, which consists of a Lithium-Ion battery pack containing two 3.7 VDC Li-Ion cells in series.
1.1.1 Accessories
The cable connecting the hand-held devices with the base unit.
1.2 Separate Power Supply Source (Mains Supply Transformer)
This device is specied to be connected only to the Lithium-Ion battery charger, Model 2241P 2-cell Li-Ion from Mascot.
1.3 Essential Performance and Basic Safety
The device does not have an essential performance, the absence of which may result in an unacceptable risk. Basic safety is
maintained when the device is stored, handled, and operated in normal conditions, and in accordance with its normal use and
intended use.
1.4 Temperature Range for Use Indoors:
Charge of batteries: 0ºC to 35ºC ±5ºC (The device is connected to the battery charger but not used on a patient).
Discharge of batteries: 0ºC to 28ºC (The device is used on a patient whether connected to or disconnected from the battery charger).
Storage: -20ºC to +50ºC (Short or long-term transportation and storage when not using the device).

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1.5 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 uid leakage, heat generation, re or battery explosion. Failure to follow the
security precautions and instructions for use may lead to a potentially dangerous exposure of the eyes (by intra beam viewing at
close range), or thermal skin injury (by applying high output power on dark pigmented skin).
To prevent these situations from occurring, as well as to ensure safe use of the device, the security precautions mentioned in this
manual should be strictly observed.
1.6 General Caution and Warning Statements
“WARNING: The use of controls, adjustments to the device, or performance of procedures other than those specied 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 modication of this equipment is allowed.” This statement addresses the HAZARDS that can follow an unauthorized
modication of the ME EQUIPMENT, e.g., BASIC SAFETY may be compromised by a modication or an alteration of the normal
condition of the device.
This device is a Class 3B laser product. Warning: Do not look at direct and non-diffuse reections and avoid intra-beam viewing.
Safety glasses are provided with every ProSeries purchase.
1.7 Licensing
The use of the device may require you to be licensed (subject to the jurisdiction you are located in). You should make your own
inquiries regarding any license, or any other form of registration.

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2. DEVICE DESCRIPTION AND USE
This device is a transportable, battery-operated medical laser product, with which the operator administers non-invasive transient
class 3B infrared or visible laser light to reduce pain and inammation, as well as to promote tissue repair and recovery. This device
is intended to be used as a supplementary treatment modality intended to be operated by a variety of practitioners, e.g., doctors,
nurses, veterinaries, dentists, physiotherapists, dermatologists, chiropractors, and massage therapists. The treatment modality of
medical laser devices is commonly called Low Level Laser Therapy (LLLT), or laser therapy.
Laser is an acronym for Light Amplication by Stimulated Emission of Radiation and emits light with unique properties, which
combined cannot be found in any other light source. These properties can be described briey as monochromatic, coherent and,
generally, highly polarized. Light consists of oscillating electric and magnetic waves, and our vision interprets colours on the basis of
the wavelength content of the light as it enters the pupil and hits the retina.
The wavelength is described as the distance between repeating units of these waves and is measured in nanometers (nm). Light
with wavelengths shorter than about 400 nm (ultraviolet) and longer than 800 nm (infrared) are not perceived as visible to the human
eye. Visible light, when described in nm, are as follows: violet 420 nm, blue 470 nm, green 530 nm, yellow 580 nm, orange 610
nm, and red 700 nm. The light intensity (output power) of lasers is measured in Watts (W). Laser light can be pulsed or continuous,
and the beam can be focused, divergent or collimated. A wide range of lasers are used in laser therapy, and the characteristics and
parameters vary depending on their intended use.
Given the magnitude of treatment parameters, e.g., peak power, average output power, power density, spot size, wavelength, pulse
frequency, duty cycle, aperture design, beam formation, exposure time, treatment procedure, number of sessions and treatment
intervals, etc., it may be difcult for the clinical practitioner to know how to administer effective treatments without a properly
designed device and the assistance of a user manual.
2.1 Device Design
Laser light applied to the skin or tissue may be absorbed, reected, transmitted, or scattered. In order to perform the most efcient
treatments, the laser light has to be able to penetrate and reach the area intended to be treated. Supercially situated conditions,
such as open wounds, therefore require a lower dose, power and transmittance compared to those that are situated deep down
within the tissue, for example in muscles and joint disorders.

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This device is designed to enable the operator to administer efcient and safe laser treatments with ease. Generally recommended
parameters, which are considered optimal for each treatment point on the basis of studies and clinical practice, have been built
into the design and the controls of the device. The parameters and the dosages are automatically set by the treatment controls.
The laser and the aperture design ensure practicable contact application and improved transmission of light through the tissue.
Treatment intervals, number of sessions, application specication and use are described in this manual. The device complies with
regulatory requirements, harmonized standards, and the medical device directive in order to ensure safe use and a high-quality
standard. The device has been third-party tested (CB scheme) to ensure compliance with regulatory requirements.
2.2 Operation Description of Laser Treatment (General)
Treatment is performed by applying a generally optimal dose of laser energy onto and around a condition, using a point-by-point
application procedure. An audible and visible signal informs the operator when to switch the application point. At each signal, the
laser aperture is moved approximately 1,5 cm until the whole condition area has been covered.
The device has four different treatment controls that adjust the dosage and power according to whether the condition intended to
be treated is situated supercially, low, intermediate or deep within the tissue. The operator selects and presses the respective
treatment control button and places the laser apertures in contact with intact normal skin, or in non-contact (approximately 2 to 5 cm
air distance) with sensitive and broken skin or open wounds. The operator then presses the laser emission control button to start the
laser treatment, holds the device in position, and switches application point at each signal. When the area surrounding the condition
has been covered, the operator presses the laser emission control button to stop the laser emission and reads the LCD display for
medical record keeping.
2.3 General Risks and Hazards with Class 3B Lasers
Class 3B lasers with an average output power of 500mW or less can potentially cause eye injuries. If the beam is focused to
deliver a high-power density treatment, it can cause skin injuries when absorbed into dark pigmentation. 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 of up to 60Hz may trigger photosensitive epilepsy.

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2.4 Device Overview Base Unit / Table-Top Unit

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2.5 Device Overview Hand-Held Units (Laser Probe)

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3. PRIMARY OPERATING FUNCTIONS
a) Use the key switch to put the device in operational mode (unlocking the device for use). The device enters a STAND-BY state.
b) A yellow Light Emitting Diode (LED) is lit when the key switch is turned, indicating STAND-BY.
c) Press and release the push button to turn on the device (activate the device). The device enters a READY state.
d) A green LED on the push-button indicates that the device is in READY state.
e) LEDs on the keypad are lit in sequence, and several audible signals inform the operator that the device is ready for use.
f) The operator selects a treatment control according to the location and depth of the condition or disorder. The symbols of the
controls are supercial , low , intermediate and deep .
g) When a treatment control button is pressed, the adjacent LED is lit for verication.
h) Place the laser apertures either in contact with dry intact skin at the location for treatment or in non-contact
(with approximately 2 to 5cm air distance between the laser apertures and the patient) if the skin is broken and sensitive,
as well as over open wounds.
i) Press and release the laser emission control button to start laser emission (start of action).
j) An audible signal indicates the start of laser emission. The laser aperture LED(s) is lit, indicating laser emission.
k) Hold the device in position.
l) An audible and visual information signal informs the operator when a generally optimal laser energy dose per application point
has been delivered.
m) Move the applied part (or laser apertures) approximately 1, 5 cm and wait for the next audio/visual information signal.
n) Repeat until the entire area on and around the condition or disorder has been covered (i.e., a shoulder, knee, an elbow).
o) Press and release the laser emission control button to stop laser emission (stop of action).
p) Two audible signals indicate the stop of laser emission. The laser aperture LED(s) is switched off, indicating that no laser
radiation is emitted.
q) Remove the device from the patient.
r) Read the LCD display for medical record keeping (treatment time and dosage in Joules).
s) Press and release the push-button (ON/OFF) to turn off the device (the device enters STAND-BY).
t) Use the key switch to deactivate the device (i.e., lock the device).

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u) Remove the key.
v) Clean the device with disinfectants (see 10.1).
w) Place the device in a safe and dry location (storing).
x) Make sure that the Li-Ion charger is unplugged from the mains supply (wall socket or similar).
3.1 Charging of The Battery
The device is intended to be used within the temperature range of 0 – 28ºC, and charged within the temperature range of 0 – 35ºC
± 5ºC. When the temperature of the battery exceeds 35ºC ±5ºC, the charging is automatically stopped by a thermal switch. Charging
will not be possible again until the temperature of the battery has returned to a temperature of lower than 35ºC ± 5ºC.
1. Turn off the device with the key switch and remove the key.
2. Connect the cable connector of the Li-Ion charger to the battery charger on the device.
3. Connect the charger to the mains supply (wall socket).
4. Check that the Light Emitting Diode on the Li-Ion charger is lit (the colour orange/red indicates the charging of the battery).
5. If the orange Light Emitting Diode is not lit, remove the charger from the mains supply and wait until the green Light Emitting
Diode is switched off. Connect the charger to the mains supply and retry.
6. Charge the battery under supervision (do not leave the device unattended).
7. The battery is fully charged when the Light Emitting Diode on the charger turns green.
8. Remove the charger from the mains supply (wall socket) when the device is not used or is unattended to.
9. Disconnect the charger from the device by removing the cable connector.
10. Store the Li-Ion charger in a safe and dry location.
If the Light Emitting Diode on the charger blinks between green and orange/red it might be caused by either:
• The temperature of the battery may be too high. Make sure that the device is cooled down to a temperature lower than
35ºC ± 5ºC, but not lower than 0ºC.
•Failure of charger, battery or connector. Contact service for support.

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If the Light Emitting Diode on the charger is not lit – neither green nor orange – then the charger is not functioning as intended.
Contact service for support.
Note: The device can be used without a connection to the charger. When used without connection to charger, the battery
time before the need to recharge will vary depending on which hand-held laser devices (laser probes) are used. When
used only on battery, the thermal switch protecting the battery charge/use may be overheated which will result in a shut-
down mode of the Base Unit. In this mode, the LCD-displays will no longer be lit and the Base Unit cannot be used until the
thermal switch has returned to a temperature of lower than 35ºC ± 5ºC, which may take up to 15-20 minutes.

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4. TREATMENT CONTROLS
The treatment controls are indicated by the following symbols: When a control button is pressed, the device sets
automatically the parameters required for delivering a generally optimal dose per application point onto and around a condition.
When pressed, the Light Emitting Diode (LED) next to the control button is lit and the output power (in mW) and dose (in Joules) and
time set signal per application point is shown on the LCD display.
The operator identies at which approximate tissue depth, from the skin surface down, the condition or disorder is located. The
corresponding treatment control button is then selected and pressed.
The operator presses and releases the laser emission control button to start the laser treatment, holds the device in position and
switches application point at each signal by moving the device approximately 1,5 cm to a new application point adjacent to the one
before. Treatment is ended when the area surrounding the condition or disorder has been covered.
Caution
By using the treatment control ( ), the hand-held device (laser probe) can become hot after 10 minutes. If the device is switched
on with this setting, but not used for more than 10 minutes, the applied part (the nut that holds the lens at the laser aperture)
may become 51°C. If placed in skin contact and with pressure in this condition, it may initially be uncomfortable for the patient.
The temperature of the applied part will, however, drop within a few seconds due to heat dissipation in tissue and become the
same as the skin +2.5°C. The skin temperature will not be elevated by more than +2.5°C.
Recommended Use From The Manufacturer
When the applied part becomes hot by using the setting ( ), switch to ( ) and use it for two signals per point instead of one.
By using a lower treatment setting, the temperature of the applied part will drop much faster. Once the applied part has cooled,
one can switch back to the original setting ( ).
4.1 Overview Chart of The Treatment Controls
The treatment controls overlap each other. There is no risk of harm using one control instead of another. The operator is advised
to use the control he or she nds most suitable or which corresponds best to the condition or disorder to be treated. The use of the
following controls is to be regarded as guidelines.

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Overview per laser diode
Treatment control button Adjustment/setting Laser type/output power Signal
Lowest output power
Lowest dose/time per point
904 nm 60 mW 10 seconds / 0.6 J
808 nm 80 mW 30 seconds / 2.4 J
660 nm 25 mW 30 seconds / 0.75 J
635 nm 25 mW 30 seconds / 0.75 J
520 nm 25 mW 30 seconds / 0.75 J
450 nm 25 mW 30 seconds / 0.75 J
Low output power
Low dose/time per point
904 nm 60 mW 30 seconds / 1.8 J
808 nm 150 mW 30 seconds / 4.5 J
660 nm 50 mW 30 seconds / 1.5 J
635 nm 50 mW 30 seconds / 1.5 J
520 nm 50 mW 30 seconds / 1.5 J
450 nm 50 mW 30 seconds / 1.5 J
Intermediate output power
Intermediate dose/time
per point
904 nm 60 mW 60 seconds / 3.6 J
808 nm 300 mW 30 seconds / 9.0 J
660 nm 75 mW 30 seconds / 2.25 J
635 nm 75 mW 30 seconds / 2.25 J
520 nm 75 mW 30 seconds / 2.25 J
450 nm 75 mW 30 seconds / 2.25 J

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Highest output power
Highest dose/time per point
904 nm 60 mW 120 seconds / 7.2 J
808 nm 500 mW (808-1) 30 seconds / 15.0 J
808 nm 400 mW (808-3) 30 seconds / 12.0 J
660 nm 100 mW 30 seconds / 3.0 J
635 nm 100 mW 30 seconds / 3.0 J
520 nm 100 mW 30 seconds / 3.0 J
450 nm 100 mW 30 seconds / 3 J
NOTE: The hand-held laser probes may contain more than one laser diode. The table above shows the values for one laser aperture applied to one
treatment point.
4.2 Treatment Application
The examples in the chart below are general guidelines based on patients with normal height and body fat, and with skin phototype
I-III. Adjustments may be necessary for patients with other skin phototypes or with dissimilar heights and sizes and amounts of
body fat.
Application Laser type/
Wavelength
Treatment setting/
Energy/power
per diode
Treatment time per
application point Application technique
Intact skin 904 nm 0.6 J to 18.0 J 10 s to 5 min Contact with skin
Intact skin 808 nm 80 to 500 mW 10 s to 5 min Contact with skin
Intact skin 660 nm / 635 nm 25 to 100 mW 10 s to 5 min Contact with skin
Intact skin 520 nm 25 to 100 mW 10 s to 5 min Contact with skin
Intact skin 450 nm 25 to 100 mW 10 s to 5 min Contact with skin

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Broken or sensitive
skin, wounds
904 nm 0.6 J to 7.2 J 10 s to 2 min
Non-contact, at air
distance of 2 to 5 cm,
Hold still or Sweep over
the surface
Broken or sensitive
skin, wounds
808 nm 80 to 150 mW 10 s to 2 min
Broken or sensitive
skin, wounds
660 nm / 635 nm 25 to 100 mW 10 s to 2 min
Broken or sensitive
skin, wounds
520 nm 25 to 100 mW 10 s to 2 min
Broken or sensitive
skin, wounds
450 nm 25 to 100 mW 10 s to 2 min
NOTE: Contact pressure of 1 to 5 N (Newton) is when the operator presses the device against the skin to remove blood from the tissue (in the same
way as when a nger 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.