therapeutic medical laser - theralase® · tlc-2000 therapeutic medical laser 1 document: 600 -0013...

TLC-2000 THERAPEUTIC MEDICAL LASER

Document: 600-0013

Table of Contents 1) Safety Information – Please Review Before Using the Theralase™ System .................................................................................... 1

Labeling and an Explanation ....................................................................................................................................................................................... 1 TLC-2000 Labels and Symbols ......................................................................................................................................................................... 2

Key Equipment Safety Features .............................................................................................................................................................................. 3 Hardware ..................................................................................................................................................................................................................... 3 Operational Safety .................................................................................................................................................................................................. 4 Precautions ................................................................................................................................................................................................................. 4 Safety Warning ......................................................................................................................................................................................................... 5 Disclaimer Information ........................................................................................................................................................................................... 6

2) THERALASE™ TLC-2000 SERIES PRODUCT INFORMATION ................................................................................................ 7 Product Overview and Technical Description ................................................................................................................................................ 7

The Power Pack (TLC-2002) .............................................................................................................................................................................12 The Power Supply (TLC-2003) ........................................................................................................................................................................ 13 Laser Probes (TLC-2001) ................................................................................................................................................................................. 14 Accessories ............................................................................................................................................................................................................... 16

Contraindications in the use of Laser Therapy ................................................................................................................................................ 18 Cautions in the use of Laser Therapy ................................................................................................................................................................ 18

3) START-UP INFORMATION ................................................................................................................................................................... 21 The Power Pack (TLC-2002) ..................................................................................................................................................................................21 The Laser Probe (TLC-2001) ................................................................................................................................................................................. 22 The Computer Tablet (TLC-2004) ................................................................................................................................................................. 24 Set-Up Procedure ........................................................................................................................................................................................................ 25

4) SYSTEM OPERATION OVERVIEW.................................................................................................................................................. 27 Steps for Advanced Treatment.............................................................................................................................................................................. 27 Steps for Basic Treatment ........................................................................................................................................................................................ 28 Stop Procedure ............................................................................................................................................................................................................. 28 Overview of the Menu ............................................................................................................................................................................................... 29 System Operation in Detail ......................................................................................................................................................................................30 Advanced Operations................................................................................................................................................................................................ 34 Administrator Functions ............................................................................................................................................................................................ 34

5) Maintenance and Service ............................................................................................................................................................................. 36 Inspection and Cleaning ............................................................................................................................................................................................ 36 Transport ......................................................................................................................................................................................................................... 36 Calibration/Repair of the Laser Verification Unit ............................................................................................................................................ 37 Service of Laser Diodes ............................................................................................................................................................................................. 37 Product Warranty ........................................................................................................................................................................................................ 37 Environmental Considerations ............................................................................................................................................................................... 37 Theralase™ Customer Service Contact Information ...................................................................................................................................... 37

6) Electro Magnetic Compatibility Information ......................................................................................................................................... 38


1 Document: 600-0013

1) SAFETY INFORMATION – Please Review Before Using the Theralase™ System

The Theralase™ TLC-2000 therapeutic laser is a Class 3B medical laser and as such is a potential hazard for direct and indirect viewing of the laser light.

The Theralase™ TLC-2000 system is composed of four main components: The Computer Tablet, the Power Supply, the Power Pack and the Laser Probes. The Laser Probes are the applied parts of the system. Safety and safe use of the product are indicated both visually by the use of labels as well as equipment features. These will be detailed below.

NOTE: It is important to be well aware of all these safety details prior to using the equipment.

NOTE: In Canada, the device is to be installed and operated according to the requirements of the following

standard: CSA - Z386-14 Safe Use of Lasers in Health Care. Caution: Federal law restricts this device to sale by or on the order of a licensed healthcare

practitioner.

Labeling and an Explanation

TLC-2001 Laser Probe

TLC-2002 Power Pack

Figure 1. Location of the safety symbols on the Theralase™ TLC-2000 System.

TLC-2003 Power Supply



TLC-2000 Labels and Symbols

Canadian Standards Association Symbol (for Canada and US): Certifies that the product bearing this mark meets or surpasses CSA guidelines for Medical Electrical Device Standard 60601-2-22/IEC 60825-1:2007 (2nd Edition).

ATTENTION Consult ACCOMPANYING DOCUMENTS Symbol: Documents accompanying EQUIPMENT or an ACCESSORY and containing all important information for the USER, OPERATOR, installer or assembler of EQUIPMENT, particularly regarding safety.

Class 3B Laser Warning Label Symbol – APERTURE LABEL: Identifies product as a Class 3B laser, which permits human access to laser radiation in excess of the accessible emission limits of Class 1 and Class 2, but which does not permit human access to laser radiation in excess of the accessible emission limits of Class 3B for any emission duration and wavelength.

Type BF Equipment: Class 1 ME EQUIPMENT providing a particular degree of protection against electric shock, particularly regarding allowable LEAKAGE CURRENT and reliability of the protective earth connection. Includes an F-TYPE APPLIED PART.

Laser Radiation Warning Label: VISIBLE AND INVISIBLE LASER RADIATION. AVOID EXPOSURE TO BEAM. 905nm LASER: PULSE DURATION 200ns; PULSE FREQUENCY 10kHz; PULSE ENERGY 0.8µJ; TOTAL AVERAGE POWER: 1000mW; (5 x 200mW) DIVERGING ANGLE 14o x 23o

660nm LASER: PULSE DURATION 85µs; PULSE FREQUENCY 10kHz; PULSE ENERGY 0.04µJ; TOTAL AVERAGE POWER: 400mW; (4 x 100mW) DIVERGING ANGLE 16o x 22o IEC 60825-1: 2014 (3rd Ed)

Prescription Only Symbol Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner.

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Operation Temperature Range Symbol This equipment shall be operated within 0° to 25° Celsius ambient temperature and maximum altitude of 2000 m.

European Authorized Representative Obelis s.a. Corporate Office: Registered address : Bd. Général Wahis 53 Avenue de Tervuren, 34, box 44 B-1030 Brussels, Belgium B-1040 Brussels, BelgiumPhone: 32.2.732.59.54 Fax: 32.2.732.60.03

Fragile Symbol Do not drop.

Humidity Range Symbol This equipment shall be operated within 0% to 80% relative humidity.

Keep Dry Symbol This equipment shall be operated within 0% to 80% relative humidity.

Figure 2. Safety Labels and detailed explanations of the symbols.

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EC REP



Key Equipment Safety Features

Hardware In addition to the safety signs placed on each of the elements of the Theralase™ system, key safety features are built into the TLC-2000 Power Pack and Tablet software as well. These are illustrated below.

Figure 3. Safety Features.

1. Emergency Stop: This button shuts down the entire laser system immediately when pressed.

2. ON/OFF Key Switch: This is the main on / off switch for the laser system. When not in use, the keys can be placed in a safe location to prevent unauthorized use of the equipment.

3. Remote Interlock Connector: The Remote Interlock Connector is a connector that may be removed for disconnecting the main power.

4. Laser Probe: The Laser Probes are the applied parts of the system. The Probe cannot operate the laser diodes unless a laser protocol has been received from the tablet software.

5. Tablet Software: Even if the Key Switch is left in the system with the Remote Interlock Connector in place and the Laser Probe(s) turned on, there is yet another security feature in place. The Laser Probe(s) cannot emit laser light unless treatment data has been received from the Theralase™ software on the tablet. To log into the operating system, the computer tablet and the Theralase™ TLC-2000 application software requires a username and password to operate.

This now completes the 6-step security protocol system to prohibit laser use by unauthorized personnel.

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Operational Safety

Caution: Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure.

The Theralase™ TLC-2000 therapeutic laser is a Class 3B medical laser and as such is a potential hazard for direct and indirect viewing of the laser light. As a Class 3B medical laser, the Theralase™ system carries the following warning:

Users must wear laser safety glasses with a minimum Optical Density (“OD”) of 4 or greater at 905nm. Suitable eye protection is required when using the TLC-2000 laser system. Use supplied laser safety eyewear (Part #: TLC-901) for patient and for all practitioners involved in the laser treatment. Two sets of laser safety eyewear have been supplied with the Theralase™ TLC-2000 laser system (1 patient and 1 practitioner pair). Please note that Theralase™ supplies Laser Safety Eyewear with all of its products and can be ordered (Part #: TLC-901) directly from Theralase™ Inc. The laser eyewear is for diffuse viewing of laser light only. The Theralase™ TLC-2000 laser output is athermic. Laser diode package cases may warm up slightly during treatment giving a feeling of warmth to a laser treatment. Under no circumstances should the patient experience a very hot or burning sensation during treatment. If this occurs, discontinue the treatment immediately and contact Theralase™ Inc. for service. The Theralase™ TLC-2000 therapeutic medical laser is a sophisticated medical device and as such should only be handled by experienced medical practitioners suitably trained in its use.

Precautions

• Make sure that the area to be treated is free from any substance that reflects or prevents penetration of the laser beam. It is recommended that areas to be treated by laser are cleansed, prior to treatment.

• Operate the laser in a well-illuminated area, as the pupils of the eye are smaller and not as easily damaged.

• Operate the laser in an area free from mirrors or polished metal surfaces to prevent accidental reflections.

• Operate the laser in a segregated area with a sign posted:



WARNING: NO MODIFICATION OF THIS EQUIPMENT IS ALLOWED.

WARNING: TO AVOID RISK OF ELECTRICAL SHOCK, THIS EQUIPMENT MUST ONLY BE CONNECTED TO A SUPPLY MAINS WITH PROTECTIVE EARTH.

• Operate the laser probes in direct contact and perpendicular to the tissue being treated.

• Align laser probes to the area to be treated before commencing laser treatment.

Safety Warning

• The TLC-2002 Power Pack is designed to operate with TLC-2001 Laser Probes only. A maximum of four

TLC-2001 Laser Probes may be connected to the TLC-2002 Power Pack at any one time.

• The Theralase™ TLC-2000 laser and all attachments are not designed to be protected from water intrusion and should never be used wet or in the accompaniment of water. If the laser system becomes wet or immersed in water, thoroughly dry the laser system and allow 48 to 72 hours in a warm environment to fully dry prior to use. If problems persist, contact Theralase™ Inc. for service.

• The Theralase™ TLC-2000 laser and all its attachments should not be used in the presence of a flammable

anaesthetic mixture with air or with oxygen or nitrous oxide.

• The Theralase™ TLC-2000 laser and all attachments are not suitable for use in the presence of strong electromagnetic field or other electrical interference.

• The Theralase™ TLC-2000 laser and all attachments are designed as an integral system and use of parts other

than the recognized accessories or parts can degrade the performance of the Theralase™ TLC-2000 laser and may result in hazardous radiation exposure.



Disclaimer Information

The TLC-2000 therapeutic laser system is a medical device and is sold to healthcare practitioners as a tool for the rehabilitation of their patients. The TLC-2000 therapeutic laser system and attachments are utilized to assist in the alleviation of their patient’s symptoms. The TLC-2000 therapeutic laser system is not promoted as a cure for any patient ailments.

The information contained in this manual is for reference only and does not preclude the practitioner from using proper judgement in the rehabilitation of their patients.

It is the practitioner’s sole responsibility to decide if laser therapy is indicated for their specific patient’s rehabilitation.

The treatment protocols detailed in this manual are for reference only and are not promoted as the only protocol available to the practitioner.



2) THERALASE™ TLC-2000 SERIES PRODUCT INFORMATION

The TLC-2000 Therapeutic Laser System is used in the adjunctive treatment of knee pain.

The TLC-2000 laser probes are used in direct contact with tissue in order to inject photons of light (905 nm invisible laser light and 660 nm visible red light) non-invasively and drug-free into tissue.

Product Overview and Technical Description

The Theralase™ TLC-2000 series of products is comprised of four main components:

• The Computer Tablet with Theralase software (TLC-2004)• The Power Supply (TLC-2003)• The Laser Probe(s) (TLC-2001)• The Power Pack (TLC-2002)

The Power Pack only supplies power to the Laser Probe(s). The Laser Probes are controlled by Theralase™ software resident on the Tablet. Under software control, the Laser Probes operate in a patient treatment mode with the power level and time based on the protocol resident in the tablet software. The TLC-2000 therapeutic laser system is portable and allows up to four (4) Laser Probes to be attached to the Power Pack.

The TLC-2000 therapeutic laser system is designed to emit 905 nanometer (“nm”) Near Infrared (“NIR”) invisible laser light and 660 nm visible red light. The clinical protocol of the TLC-2000 therapeutic laser system for adjunctive treatment of knee pain is 40 mw average power at 905 nm and 25 mw average power at 660 nm.

Figure 4. TLC-2000 Therapeutic Laser System.

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TLC-2004 Computer Tablet

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POWER SUPPLY (TLC-2003): Input Voltage / Current 100 - 240 VAC / 2.2 A, 47 to 73 Hz, single phase Output Voltage / Current + 24 VDC / 4.2 AMaximum Watts 101 WSafety Class I

TLC-2000 OPTICAL POWER OUTPUT:

EACH NEAR INFRA-RED (NIR) LASER: Wavelength 905 nm +/- 10 nm Maximum Average Power 200 mW (variable) Repetition Rate 10.0 kHz (10,000 Hz) Beam Divergence 12° x 20° (50% intensity) Pulse Duration 200 nanoseconds Total Number of NIR Lasers 5 Total NIR Laser Power 1000 mW

EACH VISIBLE LASER: Wavelength 660 nm +/- 10nm Beam Divergence 10° x 17° (50% intensity) Maximum Average Power 100 mW (variable) Total Number of Visible Lasers 4 Total Visible Laser Power 400 mW

COMPLIANCES: North America CAN/CSA- C22.2 NO. 60601-1:08,

CAN/CSA- C22.2 NO. 606001-2-10:14, CAN/CSA- C22.2 NO. 606001-2-22:08, ANSI/AAMI ES60601-1:2005 /C1:2009 (R2012) and A2 (R2012) (Corrigendum 1)

EMC/EMI IEC 60601-1-2:2007 (Ed. 3.0) Laser Safety IEC 60825-1: 2014 (3rd Ed) Global Quality Management ISO-13485

EQUIPMENT CLASSIFICATIONS: Laser Class Class 3B medical laser Risk Class 2G medical equipment Electrical Shock Protection BF Class 1 ME Water Protection IPX0 (not water-tight) EMC Class A (commercial use)

PHYSICAL CHARACTERISTICS: Power Pack Dimensions 140 mm x 140 mm Probe Dimensions 75 mm x 135 mm x 40 mm Weight 430 g

AMBIENT CONDITIONS: Storage & Transport 0o - 40o C Operation Maximum Ambient Temperature 25o C Maximum Operating Altitude 2000 m


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Laser Probe Port Unit ON Indicator Laser Probe Power ON Indicator

Remote Interlock Connector Emergency (E-STOP) Switch Key Switch

WARNING: PLEASE DISCONNECT POWER SUPPLY BEFORE SERVICING.

The Power Pack (TLC-2002)

The Theralase™ TLC-2000 laser system Power Pack (TLC-2002) is shown below. The Power Pack consists of an aluminum case, a plastic top and bottom, and a separate plastic stand that the bottom of the Power Pack fits into. There are four ports to accommodate up to four TLC-2001 Laser Probes.

The top of the unit has an emergency STOP button (red button with white arrows). The front of the unit has a key switch for switching the unit off and prohibiting the unit from unauthorized use, an interlock switch and a green ON LED. Further details of these items as well as their operation is detailed in section 2.

Figure 5. The TLC-2000 System Power Pack (TLC-2002).

The Theralase™ TLC-2000 laser system and all attachments are rated as Class 1 ME equipment, type BF and are equipped with Class 3B lasers.

Details regarding the safe use of the TLC-2000 system components are detailed in section 2 and operation of the unit in sections 3 and 4.

The following are the detachable parts for the TLC-2002:

Power Supply: TLC-2003 Power Supply (+24 VDC, 4.2 A) Laser Probe: TLC-2001 Laser Probe


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Power supply TLC-2003 plugs in to the Power Pack - TLC-2002

Power output: Voltage: +24 VDC Current: 4.0 A

Plugs in to main AC line via power cord (TLC-155)

Caution:

• Use only the TLC-2003 Power Supply (+24 VDC, 4.2 A) to power theTLC-2002 Power Pack. This is the only Power Supply approved to be usedwith the TLC- 2000 laser system.

• Outside of North America, the proper international cord set must bespecified and purchased from Theralase™ Inc. or purchased separately forthe country of preference.

The Power Supply (TLC-2003)

The TLC-2003 is a universal power supply – the input voltage range is 100VAC to 240VAC, 47 to 63 Hz, meaning that it can be safely used anywhere in the world. The TLC-2003 power supply is able to power the TLC-2002 Power Pack.

Figure 6. TLC-2003 Power Supply and Associated Line Cord.

With the proper cord set, the TLC-2003 can be plugged in anywhere in the world. The cord set (TLC-155) supplied with the Theralase™ TLC-2003 power supply is a hospital grade 115 to 120 VAC, 50 to 60 Hz approved cord set. This is built to a North American standard and was chosen to work in Canada and the United States.

Some of the key features of the TLC-2003 Power Supply include:

100-240 VAC Universal Input Meets Safety Agency Requirements In Case IEC320 Complies with EMC/EMI Regulations Single Output up to 101 Watts CE Compliant Outputs Regulated with Low Ripple Impact Resistant Polycarbonate Enclosure


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Caution: The Laser Probe Cover should be placed over the lens area when not in

Laser Probes (TLC-2001)

The TLC-2002 Power Pack is designed to operate with up to four (4) of the TLC-2001 Laser Probes. The TLC-2001 Laser Probe has a POWER ON slide switch and a BLACK pushbutton START switch. The Lasers cannot be activated until the Laser Probe receives a command transmission from the Tablet. The Probes do not retain any clinical protocols in memory when disconnected from power.

When first turned on, the Laser Probe will be in idle mode waiting for data and a command transmission from the Tablet. The Laser Probe will display the treatment time on the liquid crystal display (“LCD”) when the information is received from the Tablet. Only when the time setting is displayed will the start pushbutton have any effect. The black pushbutton may be operated once to turn on the laser diodes for the time setting displayed on the Laser Probe. The operating status of the Laser Probe will be displayed on the LCD. The display will change the Laser status to RED while the laser diodes are emitting and the time duration will count down to zero. The fans will turn on during the time the lasers are on and will stop when the time reaches zero and the laser diodes are turned off.

The Laser Probe has to be used in such a manner to encourage free air flow around it. This would discourage placing the Laser Probe under gowns, toweling or clothing if it is not absolutely necessary.

Figure 7. Top and Bottom view of the Laser Probe (TLC-2001).

The output of the TLC-2001 Laser Probe consists of:

• five (5) 905 nm, invisible, Near Infrared 200 mW maximum average power laser diodes• four (4) 660 nm, visible, red 100 mW maximum average power laser diodes


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Connecting/Disconnecting the Laser Probes (TLC-2001) to/from the Power Pack (TLC-2002)

All the Laser Probes feature a very simple medical grade push-pull cable connector. This consists of a cable with a connector assembly on each end and a receptacle assembly in the Power Pack and the Laser Probe.

Assurance of proper mating is provided by keying. The key(s) of the cable plug assembly are designated by an arrow on the plug and must align with the key of the receptacle assembly.

Figure 8. Probe Assembly illustrating the key. Note that the key is located at the 6 o’clock position.

The cable plug assembly must be properly aligned with the receptacle assembly, and then inserted until the latches engage the receptacle assembly. If needed, rotate the connector until the key is aligned. There should be no need to force the connector into the receptacle. To ensure proper mating, there must be an audible “click”.

Figure 9. Mating the Connectors – Cable Plug Assembly Key is aligned with Receptacle key.

The connectors must be unmated by first gently sliding the housing subassembly away from the receptacle assembly and then pulling the entire connector out. PLEASE hold the main body and DO NOT pull the cable.

Figure 10. Un-mating the connected assembly.


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Accessories

Accompanying the TLC-2000 system, in addition to the above main items, will be two sets of laser safety goggles (TLC- 901).

Safety Eyewear:

Two sets of laser safety goggles (part #: TLC-901) are supplied by Theralase™ as standard accessories. These laser safety goggles are provided for viewing of diffused laser light only and are not indicated for direct viewing of the laser output.

It is highly recommended that both the practitioner and the patient wear laser safety eyewear during laser therapy treatment.

Figure 11. Theralase™ supplied Laser Safety Eyewear.

Optical Density (“O.D.”) is the scientific term to describe a material’s ability to block light of a certain wavelength. It is a logarithmic formula, where the higher the O.D. value, the better the material blocks light. For example, an O.D. of 1 means the material will allow 10% of the light penetrate the eyewear at a particular wavelength.

O.D. Light Penetration Light Absorption

0 100% 0% 1 10% 90% 2 1% 99% 3 0.1% 99.9% 4 0.01% 99.99% 5 0.001% 99.999% 6 0.0001% 99.9999% 7 0.00001% 99.99999%

Optical Density Ratings of the Theralase™ approved laser safety goggles TLC-901 are as follows:

1) 190-400 nm (ultraviolet range): 5+ O.D.2) 660-670 nm (visible red): 2+ O.D.3) 800-915 nm (near infrared): 3+ O.D.


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Caution: Use only Theralase™ Inc. supplied laser safety eyewear or laser safety eyewear that meets or surpasses the above noted optical densities at the above-specified wavelengths

NEVER POINT A LASER TOWARDS A PERSON’S EYES UNDER ANY CIRCUMSTANCES

Theralase™ uses two wavelengths of diodes; specifically, 660 nm (100 mW average power) and 905 nm (200 mW average power) laser diodes.

Therefore, using the Theralase™ approved laser glasses may result in the following levels of light being transmitted to the eye (assuming of course that the laser diode is directly in contact with the laser glasses and pointed at the eyes on the individual’s face):

For TLC-901 laser safety goggle:

1) 660 nm (visible red): 100 mW x 1% = 1.0 mW (barely visible)2) 905 nm (near infrared): 200 mW x 0.1% = 0.2 mW

Hard Carrying Case

Top Case Layer Bottom Case Layer

Figure 12. Hard case for TLC-2000 system (part number: TLC-1200).


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Contraindications in the use of Laser Therapy

1. Do not treat the abdomen of a pregnant woman.

2. Do not treat any types of neoplasia, cancer or cancerous lesions (benign or malignant).

Cautions in the use of Laser Therapy

1. Never point the laser in the direction of any person’s eyes.

2. Do not treat endocrine glands such as the pancreas and the thyroid.

3. For a new patient or a patient who may be light sensitive, spot test the laser on an area of tissue to determine if theyare adversely sensitive to laser treatment.

4. If a patient is currently prescribed photosensitive medicine, NSAIDS, steroids or corticosteroid medicine, try toallow 2 weeks as a wash out period prior to laser treatment. If a wash out period is not possible, reduce the laserpower to 1/2 of the recommended power indicated and increase with each treatment as the patient reliance onphotosensitive, NSAIDS, steroids or corticosteroid medicine reduces.

5. Start treatment at the most painful area first and follow the treatment specifics. Treat surrounding tissue next.

6. Under no circumstances should the patient feel anything more than a slight warming effect. If the patient feels hotsensations, pain or burning, STOP LASER TREATMENT IMMEDIATELY and check laser equipment. If laserprobe head is hot to the touch, call immediately for service. Detailed contact information is provided in Section 5 -Maintenance and Service of this manual.

7. Under no circumstances over-treat an individual, as over-treatment may lead to bio-inhibition of tissue structures.


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3) START-UP INFORMATIONA detailed description of the individual system components.

The Power Pack (TLC-2002)

The TLC-2002 Power Pack provides power to each TLC-2001 Laser Probe. The probes’ ports, numbered 1 to 4, are the same electrical output. A TLC-2001 Laser Probe should always be connected to location #1 first.

Figure 13. A detailed look at the Power Pack.

1. Remote Interlock Connector: The Remote Interlock Connector is capable of disconnecting the TLC-2001 LaserProbe(s) from main power when removed. To remove, press the button on the connector and pull the RemoteInterlock Connector straight out. Main power is now disabled and no action will restore it until the Remote InterlockConnector is replaced. To replace, insert straight into the matching receptacle.

2. Emergency Stop: This button shuts down the entire laser system immediately when pressed, disabling main power.

NOTE: Depressing the Red Emergency Stop Button immediately disables the laser system. Operationmay be resumed by rotating the Red Emergency Stop Button 1/4 of a turn to the right and allowing it to “pop out” again.

3. Key Switch: This is the main on / off switch for the laser system. When the key is turned to the left, the system is off, disabling mains power. When the key is turned ¼ turn to the right, the system is on. The key can only be removed when in the OFF position.

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Caution: Use only the TLC-2003 Power Supply for the Theralase™ system.

4. Power Supply Input: Input for black DC adapter cord from the TLC-2003 Power Supply. When the DC adapteris connected the TLC-2000 Power Pack may be operated directly from an AC wall outlet.

5. Probe Power Ports: Power supply ports for up to four (4) TLC-2001 Laser Probes.

6. Power IN LED: This LED is illuminated only when the external power supply is connected and the key switch is inthe ON position, the Remote Interlock Connector is installed and the Emergency Stop is not activated.

7. Power OUT LED: This LED is illuminated only when both of the internal power supply voltages to the probes aregood.

Note: The TLC-2001 Laser Probes will not function if this LED is OFF.

The Laser Probe (TLC-2001)

The Theralase™ TLC-2001 Laser Probe is shown below. A feature of the Laser Probe is the use of a heatsink to keep the probe cool during use. There are different strap sizes provided with the Laser Probes to facilitate holding the probe on different aspects of the knee.

Note: Pressing the black pushbutton on the side of the TLC-2001 Laser Probe will activate the laser diodes. Pressing the button again will pause laser operation until re-commenced with the same button. After completion of a treatment, the pushbutton can be used to repeat the treatment. ARM LED must be illuminated to commence laser operation.

Figure 14. A detailed look at the Laser Probe (TLC-2001).

1. Display: A 2.4” Liquid Crystal Display (“LCD”) is used to display the status of the Laser Probe(armed/running/paused), laser operation (on/off), BlueTooth® quality, treatment time, number of points treated,and Laser Probe error messages.

2. Display Window: The display window is made from optically transparent acrylic plastic and can be cleaned withisopropyl alcohol. Refer to “Guideline for Disinfection and Sterilization in Healthcare Facilities”, 2008, Centers forDisease Control and Prevention (CDC) for more details.

3. Power On/Off Switch: Slide this switch forward to turn on the Laser Probe. Slide the switch back to turn off theLaser Probe.


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Caution: NEVER look directly into this area with the lasers on.

4. Start/Stop Button: This button is used to start/stop the Laser Probe laser light emission. Press this button once tocommence emission of laser light. Pressing the button once, while the probe is operating, will suspend thecountdown and turn off laser emission. The operation and countdown can be resumed by pressing the button in thecorrect start sequence again.

5. Laser Diode Aperture: This area is where the laser energy is emitted and is the treatment contact area. There arefive (5) 905 nm invisible, Near Infrared 200 mW maximum average power laser diodes and four (4) 660 nm, visible100 mW maximum average power, red laser diodes.

6. Laser Output Window: The laser output window is an optically transparent acrylic plastic mounted to a ring. Thewindow is removable by turning the ring left until it stops and lifting the ring straight off the probe. The window iscoated to be scratch resistant. It keeps the lasers clean and can be wiped with isopropyl alcohol. Windows thatbecome scratched should be replaced. Replacement windows can be ordered directly from Theralase™.

7. Laser Probe Cover: The Laser Probe cover attaches to the probe by magnets. The cover protects the windowduring storage. It is recommended that the cover be installed when the Laser Probe is not in use.

8. Probe Body: The Laser Probe body is molded from Bayblend FR2000, a medical grade, fire retardant PVCmaterial. This material is impervious to most cleaning and sterilizing solutions, and is cleaned with isopropyl alcohol.

9. Strap Handles: Straps to hold the Laser Probe in place on the treatment area attach to these handles on the sidesof the Laser Probe.

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The Computer Tablet (TLC-2004)

The Computer Tablet comes with the Theralase™ software already installed and the keyboard and touch screen together. The touch screen can be separated from the keyboard if desired. There is a pop up touch screen keyboard; however, it may be easier to input data using the attached keyboard. With the keyboard attached, selections can be made using the cursor or the touch screen.

When delivered, the Computer Tablet has an administrator username and password. It is recommended that the system be configured for new passwords and user names. Refer to the section Setting Username and Passwords in the Administrator Menu section for this procedure.

The Computer Tablet is shipped with the manufacturer’s user manual and software license card. Refer to those documents for additional information.

Figure 15. A detailed look at the tablet.

1. Power On - Hold this button down for two (2) seconds until the touch screen turns on.

2. Charger & Charging Port - Plug the micro USB connector from the charger into this port to power the tablet from AC voltage.

3. Touch Pad - Use this pad to control the cursor and make selections by moving your finger over the surface of the touch pad. Press the lower left corner of the touch pad to make a selection.

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Set-Up Procedure

1. Unpack the contents of the case and identify each of the pieces as outlined in the figure below. Identify the followingcomponents of your TLC-2000 system:

1. Computer tablet (TLC-2004)2. Tablet power supply and cable3. Power Supply (TLC-2003)4. Medical AC power cable5. Power Pack (TLC-2002)

6. Laser Probe(s) 1 to 4 (TLC-2001)7. Probe cable(s) 1 to 48. Safety Eyewear

Figure 16. TLC-2000 system components. 1

2. Set the TLC-2002 Power Pack on a steady surface and ensure the key switch is in the “off” position. Make allconnections as shown below and read the following set of instructions BEFORE operating the system.

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3. Connect the 120 VAC hospital grade line cord (TLC-155) into the TLC-2003 Power Supply (or approved HospitalGrade cord set for country of use) and then connect the TLC-2003 Power Supply into the power input located onthe Power Pack.

4. Connect the Laser Probe(s) (TLC-2001) to the Power Pack (TLC-2002) by inserting the medical grade push-pullconnector to mate with the receptacle in the Laser Probe port.

Note: Port 1 MUST be used for one of the Laser Probes. Detailed instructions on how to connect the LaserProbe to the Power Pack is given in section 3. Leave the Laser Probes turned OFF.

Note: Connect the Laser Probe(s) to the Power Pack PRIOR to switching the Power Pack ON.

5. Connect the Computer Tablet power supply to the micro USB connector on the Computer Tablet and plug into a 120 VAC source. The power supply is universal and will need a plug adaptor for 240 VAC.

6. Open the Computer Tablet and turn it on. Then log into the operating system with the supplied username and password.

7. Select the TLC-2000 icon and enter the username and password to start the application.

Note: There is a user name and password for the Computer Tablet and also for the TLC-2000 software.

8. At this point the Theralase™ TLC-2000 Clinic Desktop screen should be displayed with icons for the actions.

9. Turn on the Power Pack by:

a. Turning the Emergency Stop switch a quarter turn clockwise to allow it to “pop” outb. Inserting the Remote Interlock Connector into its receptacle on the front panel of the Power Pack until it

locks firmly into placec. Turning the Key Switch 90° to the right

10. At this point the Power Pack Power IN and Power OUT LEDs should illuminate.

11. The system components are now set up and ready to be used.

Note: The Theralase™ software must be operating with patient data in the database BEFORE the Laser Probes will emit laser light.


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4) SYSTEM OPERATION OVERVIEW

Steps for Advanced Treatment

To operate the Advanced TLC-2000, the basic steps are:

1. From the Theralase™ TLC-2000 Clinic Desktop, tap the Advanced Treatment tab.

2. Enter the patient’s name in the search field.

3. If the patient is not in the database, tap the New Patient button and input patient data into the software database andsave. Otherwise, go to step 4.

4. Select the patient’s name.

5. Select the To Diagnoses button.

6. Select the diagnosis that is to be treated.

7. If no patient diagnosis is in the database, tap the New Diagnosis button and select the condition to be treated from the listand save. Otherwise, go to step 8.

8. Select the Start New Treatment button.

9. Input the patient’s pain scale and press the Save button. The Treatment Control Panel will pop up.

10. Place the probe on the patient treatment area.

To perform a treatment:

1. Select the Measurement Mode button for one of the available Laser Probes and press the Black Start pushbutton once onthe Laser Probe. This will determine an optimal protocol for the particular patient’s physical profile.

2. Having already completed a measurement, select the Treatment Mode button for one of the available Laser Probes.This communicates the time and power settings to the Laser Probe.

3. Start the treatment either by pressing the Black Start pushbutton on the side of the Laser Probe or the Start buttondirectly on the software itself.

4. The laser diodes will emit laser light and the time will start to decrement. The Laser Probe will provide visual and audibleindications during the time the lasers are emitting laser light. When the time counts down to zero the laser diodes willturn off and the Laser Probe will generate a different audible BEEP sound.

5. If treating another point, move the laser probe to the next treatment area and press the Black Start pushbutton on theLaser Probe or the Start button on the software to continue the treatment.

6. To pause the treatment, either press the Black Start pushbutton on the side of the Laser Probe or the Pause button onthe software. To resume treatment, press the Black Start pushbutton again or the Start button on the software.


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7. Press the Finish Treatment button on the Computer Tablet to exit the treatment.

8. The Laser Probe can be turned off with the slide switch on the side of the Laser Probe.

Steps for Basic Treatment

To operate the Basic TLC-2000, the steps are:

1. From the Theralase™ TLC-2000 Clinic Desktop, tap the Basic Treatment tab.

2. Select the diagnosis that is to be treated, followed by the protocol to be used: Standard, Sport and High BMI, Low BMIand Geriatric, or Dark Skin, and press the Save button. The Treatment Control Panel will pop up.

3. Place the probe on the patient treatment area.

4. Select the Treatment Mode button for one of the available Laser Probes. This communicates the time and powersettings to the Laser Probe.

5. Start the treatment either by pressing the Black Start pushbutton on the side of the Laser Probe or the Start buttondirectly on the software itself.

Stop Procedure

The Laser Probe may be turned off during operation by any of the following means:

1. Slide the switch on the Laser Probe to the OFF position.

2. Press the Stop button or the Finish Treatment button on the Computer Tablet software.

3. Press the Red Emergency Stop Button to stop Laser Probe operation and disable the mains power to the TLC-2000laser system. Laser operation can only be re-started by turning the E-STOP switch a quarter turn clockwise to allow it to“pop” out.

4. Turn the on / off power key switch to the left ¼ turn to stop laser operation and to disable the mains power to the TLC-2000 laser system.

The Key Switch or Remote Interlock Connector may now be removed, if desired, to disable the laser system fromunauthorized operation.

Note: Even if the Key Switch is left in the system and the Remote Interlock Connector is in place, the securitypassword must be known to enable laser operation; thereby, providing a 3-step security protocol to prohibit laser use by unauthorized personnel.


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Overview of the Menu

Custom Settings Create Custom Protocols

Use this tab to create a custom protocol. Enter the power level for 905nm and 660nm, treatment duration, protocol name, and body region to be treated.

Advanced Treatment Customized Treatment Options

Basic Treatment Preselected Treatment Options

Use this tab to perform a patient treatment. Enter the patient information and diagnosis for treatment.


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System Settings Administrator Access

Permissions: This tab is used by an administrator to set up control of access to the TLC-2000 software.

Users: This tab is used by an administrator to set-up TLC-2000 system users.

Synchronize: This tab is used to Upload client data and Download cloud data.

Probes: This tab is used to configure Probes to the TLC-2000 software via BlueTooth®.

System Operation in Detail

Common Operations

Turning the Computer Tablet ON:

Turn on the tablet by pressing and holding the power on button on the lid of the tablet for two (2) seconds. Keep it pressed until the screen starts.

Turning the Computer Tablet OFF

To turn the tablet OFF, tap the window icon at the bottom left hand edge of the screen. A vertical menu will be displayed. (To close the vertical menu, tap anywhere on the desktop screen.) Touch the power icon and select SHUT DOWN from the pop up window.


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Log into the Computer Tablet

Touch any key on the keyboard to go to the system Login screen. Enter the system password to display the desktop with the Theralase™ TLC-2000 application icon.

Launching the TLC-2000 software

To launch the Theralase™ application, double touch the icon and the application Sign In window will appear.

Enter the username and password and tap the sign in button once. The main menu will be displayed on the screen.

Entering Patient Information

Tap the Advanced Treatment Tab once to enter the Patient Search menu.


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For existing patients, enter Patient Name in Search field. Select the Patient and press the Edit Patient button and Patient Profile window will open.

For new patients, select the New Patient button and the Patient Profile window will open.

Fill in all the data fields and save. A confirmation window will appear. Check that the data is correct. Continue if correct, otherwise cancel and make the corrections.

The window will close and return to the Patient Search window. The patient name will be highlighted. Select the To Diagnoses button to proceed to the Patient Treatment Diagnoses window.

For existing diagnoses, select the diagnosis to be treated and select the Start New Treatment button. For a new diagnosis, select the New Diagnosis button and the Diagnosis window will open.

Touch the body part to be treated. The different conditions will be listed to the right of the body image. Select the appropriate condition. Select the date of injury. Review the measurement and treatment procedure. Save the data. A confirmation window will appear. Check to be sure the information is correct before saving. On saving, the confirmation window and Patient Data will close returning to the Patient Treatment Diagnoses window.

Note: The only approved treatment protocol at this time is knee pain.


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Treating the Patient

From the main menu, select the advanced treatment tab. The Patient Menu will open. Enter the patient name to search for the patient. The patient’s name will be listed. Select the patient and select the To Diagnoses button. Select the condition to be treated. Select a Laser Probe and turn it on. The Laser Probe will initialize and go into the Idle mode waiting for commands from the tablet.

Select the Laser Probe window that is color matched to the probe. Select the Treatment Mode. The Laser Probe will Beep and go into the ARMED state.

Place the Laser Probe on the area of the patient to be treated. Start the treatment by pressing the Start button on the software or the black Start pushbutton on the Laser Probe once. The laser diodes will turn on and the time will start to decrement. When the time reaches 0:00 the laser diodes will turn off and the Laser probe will return to the Armed state.

At this point the Laser Probe can be turned off or another treatment cycle can be started by pressing the Start button when the treatment is finished. Exit the treatment mode by touching the Finish Treatment button on the Tablet in the Laser Probe window. The Laser Probe can be turned off at this point.


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Advanced Operations

How to Create Custom Protocols

From the main menu, select the Custom Settings tab. The Custom Settings menu window will open. Hit the plus button to start inputting the new information. Enter the power levels that you would like assigned to the 905nm laser diodes and the 660nm laser diodes and then the duration of time. Enter a protocol name and select the body region for which this protocol will be used from a convenient drop down menu. Hit the save button. You will see your new custom protocol appear on the right hand side of the screen. To create a new custom protocol, simply hit the plus button again. To delete a custom protocol, first select the protocol that you would like to delete, and once it is highlighted, click on the button with the trash can.

Administrator Functions

You will need to login to the software with the Administrator password to perform these functions. From the main menu, select the System Settings tab. The System Settings Menu window will open.

To Set User Permissions

Select the Permissions Tab. Select a name from the list and select the permissions in the check boxes. Save the changes.


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To Add/Remove Users

Select the Users Tab. Hit the plus button to start inputting the new information. Fill in the data fields with the user name, password, and name of the person. Check the box to determine the group: usually Practitioner. Reserve Administrator for one or two users. Save the data. To remove a user highlight the name from the list and touch the trash can icon.

To Adjust Probe Volume

Select the Probes Tab. You can adjust the volume of the probe(s) by adjusting the sliding scale displayed underneath the Probe Volume Adjustment section. Move the slider to the right to increase the volume. Move the slider to the left to decrease the volume. Once you have selected your preferred volume level, select the Apply button and the system will adjust the probe volume.


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5) MAINTENANCE AND SERVICEThis section deals with maintenance and serviceability of the Theralase™ system by the end user. If further detailed service of your laser system is required, contact Theralase™ Inc directly for assistance. Detailed contact information is supplied at the end of this section.

Inspection and Cleaning

PRE AND POST TREATMENT

Wipe the surface of the probe with a 70% solution of isopropyl alcohol. A 70% solution of isopropyl alcohol is a universally accepted disinfectant in accordance with CDC (Center for Device Control and Prevention) Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008. William A. Rutala, Ph.D., M.P.H.1,2, David J. Weber, M. D., M. P. H. 1,2, and the Healthcare Infection Control Practices Advisory Committee (HICPAC)3.

WEEKLY

Follow the stop procedure in the basic operation section of this manual. Remove the key from the Power Pack. Disconnect the Laser Probe(s) and power input to the Power Pack. Carefully clean each of the TLC-2001 Laser Probes with isopropyl alcohol swabs being careful not to immerse the Laser Probe heads. Remove the lens cap and immerse a Q-tip into isopropyl alcohol and rotate in the laser aperture carefully to avoid damaging the laser diodes.

MONTHLY

Follow the stop procedure in the basic operation section of this manual. Remove the key from the Power Pack. Disconnect the Laser Probe(s) and power input to the Power Pack. Inspect the laser diodes for cracks or chips in the glass. A visible chip in the glass, a crack in the glass or a missing glass mandates replacement of the laser diode. Contact Theralase™ immediately for replacement of the defective / damaged laser diode.

PREVENTIVE MAINTENANCE SCHEDULE

In addition to performing the monthly inspection for physical problems associated with the laser diodes, it is also important to check the efficacy of each of the laser diode outputs. Laser diodes typically wear or drop in average power as the total usage hours of the system increases. The real time laser power indicator is used as a reference for when the laser diodes should be calibrated / replaced.

Check the optical output of each laser diode to ensure laser diode optical output at least once per week.

The TLC-2000 therapeutic laser system may only be calibrated/repaired by Theralase™ Inc. or trained personnel equipped with the proper service equipment. There are no user serviceable parts in the Laser Probe. The Laser Verification software will indicate if a laser diode service must be performed.

Transport

Remove the key from the main power switch and store in a safe location. Disassemble the laser system, carefully packing all components and taking special care with the laser probe assembly. In packing and unpacking the apparatus, be careful not to twist or kink the probe cable(s) too sharply to prevent damage to the probe cable assembly. Ensure proper storage of the Laser Probes to avoid laser diode damage. If you damage your laser diodes, please notify Theralase™ Inc. immediately for service / replacement. (Note: The laser system should be kept within 0 to 40°C, 500 hPa to 1068 hPa and 0 to 80% relative humidity during transport).


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Caution: Calibration must only be performed by Theralase™ Inc. or by trained personnel possessing the proper knowledge and test equipment. Contact Theralase™ Inc., if after testing, software indicates maintenance of the laser diodes is required.

Calibration/Repair of the Laser Verification Unit

Calibration or repair of the real-time Laser Probe Cover is not a process that can be performed in the field. There are no user serviceable parts in the probe. In the event, if such a situation does arise, it is recommended to call Theralase™ Customer Support at 1-866-843-5273 or email [email protected] for detailed instructions on how to best handle this condition.

Service of Laser Diodes

The TLC-2000 therapeutic medical laser system contains no user serviceable parts. If the laser diodes require maintenance, contact the factory and return the system for service.

Product Warranty

The TLC-2000 Therapeutic Laser System is warranted for five (5) full years commencing from the date of delivery. This warranty includes all parts and labour used in the repair of the TLC-2000 laser system for the term of five (5) years.

This warranty is considered null and void if the laser system has been opened, misused, physically damaged or in any other way physically tampered with.

Environmental Considerations

This product contains electronic components and as such is considered e-waste and must be disposed of responsibly. Do not dispose of this product with waste destined for landfill or incineration. This product must be recycled according to local laws & regulations. At the end of this product service life, estimated to be 10 years, the product can be returned to Theralase™ for disposal.

Theralase™ Customer Service Contact Information

Please note the following contact information for Theralase™ Customer Service. Describe the issue that your therapeutic laser system is experiencing and the customer service department will instruct you on the recommended service / replacement parts for your equipment.

Toll Free Phone: 1-866-THE-LASE (1-866-843-5273)Alternative Phone: 416-699-LASE (5273) Fax: 416-669-5250Email: Website: Address:

[email protected] www.theralase.com 41 Hollinger Road Toronto, Ontario, M4B 3G4, Canada

mailto:[email protected]

mailto:[email protected]

http://www.theralase.com/


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6) ELECTRO MAGNETIC COMPATIBILITY INFORMATIONIn accordance with clause # 5.2.x of EN 60601-1-2.

Interconnecting Cables

Cable NO. Type Length Connected From Connected To Special Accessories (ferrites, etc.)

1 Power Cord 2.37M Power Supply Power Outlet None

Warning: The use of Power Cord other than the one provided by Theralase™ Inc. for the TLC-2000 may result increased EMISSIONS or decreased IMMUNITY of the TLC-2000 system.

Warning: The TLC-2000 should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the TLC-2000 should be observed to verify normal operation in the configuration in which it will be used.

Guidance and THERALASE™ INC’s declaration- ELECTROMAGNETIC EMISSIONS

The TLC-2000 is intended for use in the electromagnetic environment specified below. The customer or the user of the TLC-2000 should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment-guidance

RF emissions CISPR 11 Group 1 The TLC-2000 uses RF energy only as a bi-product of its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronics equipment.

RF emissions CISPR 11 Class B The TLC-2000 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.

Guidance and THERALASE™ INC’s declaration- electromagnetic IMMUNITY


IMMUNITY test IEC60601 Test level Compliance level Electromagnetic environment-guidance

Electrostatic discharge (ESD)

IEC 61000-4-2

±6KV contact

±8KV air

±6KV contact Criteria A Level 3 ±8KV air

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%


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IMMUNITY test IEC60601 Test level Compliance level Electromagnetic environment-guidance

Electrical fast transient/burst

IEC 61000-4-4

±2KV for power supply lines

±1KV for input/ output lines

±2KV for power supply lines Criteria A Level 3 ±1KV for input/ output lines

Mains power quality should be that of typical commercial or hospital environment.

Surge

IEC 61000-4-5

±1KV line(s) to line(s)

±2KV line(s) to earth

±1KV line(s) to line(s) Differential mode Criteria A Level 2 Common mode ±2KV line(s) to earth

Mains power quality should be that of typical commercial or hospital environment.

Voltage dips, short interruptions and voltage variations on power supply input lines

IEC 61000-4-11

<5% (>95% dip in ) for 0.5 cycles

40% (60% dip in ) for 5 cycles


<5% (>95% dip in ) for 5 s

<5% (>95% dip in ) for 0.5 cycles



<5% (>95% dip in ) for 5 s

Mains power quality should be that of typical commercial or hospital environment. If the user of the TLC-2000 requires continued operation during power mains interruptions, it is recommended that the TLC-2000 be powered from the battery (with the system) or from an uninterruptible power supply.

Power frequency (50/60 Hz) Magnetic field

IEC 61000-4-8

3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Note: If the A.C. mains voltage prior to application of the test level.


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Guidance and THERALASE™ INC’s declaration- electromagnetic IMMUNITY


IMMUNITY

IEC60601 Test

Compliance

Electromagnetic environment-guidance

Conducted RF IEC 61000-4-6

Radiated RF IEC 61000-4-6

3 Vrms

150 kHz to 80 MHz

3 V/m 80 MHz to 2.5 GHz

[V1]V3V[E1]

V/m 3V

Portable and mobile RF communications equipment should be used no closer to any part of the TLC2000, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance

80 MHz to 800 MHz

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 surveya, should be less than the compliance level in each frequency rangeb.

Interference may occur in the vicinity of equipment marked with the following Symbol.

NOTE 1: At 80 MHz and 800 MHz, 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.

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 theelectromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measuredfield strength in the location in which the TLC-2000 is used exceeds the applicable RF compliance level above, the TLC-2000should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, suchas re-orienting or relocating the TLC-2000.

b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1]V/m


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Recommended separation distances between portable and mobile RF communications equipment

and the TLC-2000

The TLC-2000 is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the TLC-2000 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the TLC- 2000 as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output power of transmitter

W

Separation distance according to frequency of transmitter m

150 kHz to 80 MHz 80 M kHz to 800 MHz 800 MHz to 2.5 GHz

0.01 0.12 0.12 0.23

0.1 0.37 0.37 0.74

1 1.2 1.2 2.3

10 0.37 0.37 0.74

100 11.7 11.7 23.3

For transmitters rated at a maximum output power not listed above, the recommended separation distance in meters(m) can be estimated using the equation applicable to the frequency of the transmitter, where 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.