SYMBYX Biome Physio Care Infrared Laser Instruction Manual

SYMBYX Biome Physio Care Infrared Laser Instruction Manual

www.symbyxbiome.com

1. General information

This operating and user manual applies to the PhysioCare 904 nm Laser by SYMBYX. This laser device is manufactured for SYMBYX Pty Ltd of Australia by Spectro Analytic Irradia AB of Sweden. (Note: Irradia also manufacture an identical product called the MIDCARE 904 nm).

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 PhysioCare 904 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.

1.1 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 TRANSIENT PULSED CLASS 1 INFRARED A (IRA) (model 904) 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.

1.2 Separate power supply source (mains supply transformer)
Not used.

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 condition and in accordance with normal and intended use.

1.4 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.

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 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.

1.6 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.

2 Device description and use

This device is a transportable, hand-held, super-pulsed, near infrared, 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 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.

2.1 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.

2.2 General risks and hazards with class 1 lasers (IEC60825-1:2014)
Laser products that are safe to use, still hold risks associated with misuse, such as long-term direct intra-beam viewing. Class 1 laser products which emit visible radiant energy may still produce dazzling visual effects, particularly in low ambient light.

2.3 Device overview

3 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).

3.1 Replacement of batteries
See Chapter 7.4.

4 Treatment controls

4.1 Overview parameters of the treatment protocol for medical recording

5 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.

6 Device application specification

6.1 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.

6.1.1 Expected life before service required
Three to four years.

6.2 Medical purpose/intended use
Intended to reduce pain and inflammation, as well as to promote tissue repair.

6.3 Patient
Human.

6.4 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.

6.5 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.

6.6 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.

6.6.1 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).
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.

6.7 Frequency of device use
Chronic conditions: 1 – 3 treatment a week.
Acute conditions: 3 – 5 treatments a week.

6.8 Treatment/application time per patient
Treatment time varies by specific physical ailment but is usually between 1 – 15 minutes per treatment (see table below). Move the laser approximately 1.5 – 2 cm after each minute of laser treatment (i.e., the time between beeps) on or around the Treatment Area of Body, until Total Minutes of Treatment is completed.

Please read the above table in conjunction with Chapter 6.14 Patient potential reaction for first time users.

6.9 Treatment interval
Approximately every 48 hours, depending if condition is chronic or acute.

6.10 Number of treatments per patient/sessions per patient
Approximately 3 treatments per week are recommended.

6.11 Treatment session interval
Continuously.

6.12 Contraindications
Treatment of the eye through the lens; intra-beam viewing.

6.13 Side effects
No known side effects.

6.14 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 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.

6.15 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.

6.16 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.

6.17 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.
• 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

6.18 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.

6.19 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;

• 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.

6.20 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.

7. 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.

7.1 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.

7.2 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.
• 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.

7.3 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.

7.4 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.

7.5 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 17 for instructions for packaging and transporting.

8 Laser safety

8.1 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.

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.

8.2 General risks with Class 1 Lasers (see Chapter 2.2) IEC 60825-1
8.3 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.

How to check if the device emits laser radiation
– The 904 nm laser radiation is almost invisible to the eye but can be seen if photographed with some cell phone cameras when the aperture is placed close to a non-reflective material, for example, the palm of the hand. This method can be used to check that the laser emits laser radiation in those cases where there is no power meter available and the operator needs to ensure that the device is functioning.

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.

“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.

8.4 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.

9. General electrical and mechanical safety

9.1 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.

9.2 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:

9.3 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;
• 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.

10 Description of controls, messages, and indicators

11 Technical specifications (general)

12 Technical specifications

12.1 PhysioCare Laser 904 nm by SYMBYX

13 Definitions

14 Labels and symbols

NOTE. Reference for symbols. IEC60825-1:2014, IEC60601-1:2005 and IEC60878:2003

14.1 Labels on the device
These are legible reproductions of the labels and hazard warnings affixed to the device.

14.2 Symbols and marking on package label

15 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.

16 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.

17 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 + 70⁰ 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,
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.

18 Distributor and manufacturer contact information

Distributor: SYMBYX Pty Ltd. ABN 29638049073 Suite 6, 110-114 Hampden Lane, Artarmon NSW 2064 Australia.
Tel +61 (0)2 8066 9966
Email: info@symbyxbiome.com.
Manufacturer: Spectro Analytic Irradia AB. Fagerstagatan 9, 163 53 Spånga, Sweden Phone: +46-8-7672700, www.irradia.se.
For technical service and support, please contact the Distributor.

18.1 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.

19 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.
The use of ACCESSORIES, transducers and cables other than those specified herein, or those sold by the manufacturer as

19.1 Electromagnetic emissions – guidance and declaration

Guidance and manufacturer’s declaration – electromagnetic emissions

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.

• 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 PhysioCare 904 nm Medical Laser is used exceeds the applicable RF compliance level above, the PhysioCare 904 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 PhysioCare 904 nm Laser by SYMBYX.
• Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.

19.3 Separation distances – portable and mobile RF communications

Recommended separation distances between portable and mobile RF communications equipment and the PhysioCare 904 nm Laser by SYMBYX

The PhysioCare 904 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.

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.

20 Applied standards

IEC60601-1:2005:e.d 3.1, IEC60601-1-2:2014, IEC60825-1:2014, IEC60601-1-11:e.d 2, IEC62366:2014, e.d.1.1, IEC60601-1- 6:2013, e.d 3.1, IEC 62304:2006 +A:2015,ANSI/AAMI ES60601-1:2005 and CAN/CSA-C22.2 No 60601-1:08
Other standards in which the device complies with: ISO14971:2012, IEC62304:2006, ISO10993-5, ISO10993-10.

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