Multi Radiance Medical TQ Solo Portable Laser Instruction Manual

TQ SOLO™
Operating Manual

Multi Radiance Medical®
6521 Davis Industrial Parkway
Solon, OH 44139 USA
440-542-0761
www.MultiRadiance.com

TQ Solo Portable Laser

Distributed by Multi Radiance Medical
With permission
Version 1.5
Not for Resale
Text Copyright 2022, Multi Radiance Medical.
Photos, Images and Illustrations Copyright 2022, Multi Radiance Medical.
Without limiting the rights under copyright reserved above, no part of this publication may be reproduced, stored in or introduced into a retrieval system, or transmitted, in any form or by any means (electronic, mechanical, photocopying, recording or otherwise), without the prior written permission of Multi Radiance Medical. The scanning, uploading and distribution of this book via the Internet or via any other means without the permission of Multi Radiance Medical is illegal and punishable by law. Please purchase only authorized electronic or physical copies of this manual. The Multi Radiance Medical logo, brand and product names referenced herein are registered trademark(s), service mark(s) or trademarks of Multi Radiance Medical. All other brand and product names mentioned herein are trademarks of their respective owners.
This manual is intended for a variety of clinical users including: Medical doctors, chiropractors, athletic trainers, physical therapists, occupational therapists, podiatrists, and other allied health professionals.

TQ SOLO™

Foreword

Congratulations on your purchase from Multi Radiance Medical!
This manual is written for owners and operators and contains general instructions for operation along with warnings, precautionary practices and maintenance requirements. In order to maximize the use, efficiency and life of your device, please read this manual thoroughly prior to operation. This manual should be kept and referenced during the full service life of the device.
It is important to emphasize that treatment does not exclude other conventional medical treatment.
Thank you for your interest and support of Multi Radiance Medical.

Technical Specifications

Infrared radiation: 875 nm
RED radiation: 640 nm
Power Source:| Medical Grade Switching Power Adapter (supplied) Input: 100-240 V 50/60Hz 0.4 A

Class II Equipment Applied Part Type BF Laser Class 1 (IEC 60825-1)

*Equipment is not suitable for use in the presence of a flammable anaesthetic mixture of air or with oxygen or nitrous oxide.

Operational Environment

Temperature 40’C (104’F) % 10C (50F)|
---|---
Humidity 15-95% RH|
Atmospheric Pressure 70 -1060 hPa|

Storage/Transport Environment

Temperature 50’C (122F %
-20’C (4’F)|
---|---
Humidity 15-95% RH|
Atmospheric Pressure
700 – 1060 hPa|

Product Descri tion and Standard Packa e Contents

Product Description

The TO Solo offers a combination of infrared heat therapy. The device features Infrared Laser Diodes, Red LEDs and Infrared Emitting Diodes for the delivery of heat therapy. The TO Solo is a non­ invasive pain therapy system that utilizes laser, infrared, and visible red light emitting diodes (LED). It combines the clinically accepted therapeutic treatment of other low-level laser systems currently in commercial distribution into one complete, compact system. The system weighs 1 .0 pound (300 g).

Standard Package Contents

The following contents are included:

800-300M
999-312USA
Z-CA300
D-M800-300USA
D-PM8O0-300USA
D-QG800-300USA
999-500
Z-W010USA| TO Solo Laser Emitter with Rechargeable Battery
TO Solo Main Power Adapter
TO Solo Carrying Case
TO Solo Operating Manual
TO Solo Treatment Protocol Manual
TO Solo Reference Guide
Protective Infrared Googles
Warranty Card

Product Label

1. Manufacturer
2. Type BF applied part
3. Attention, see instructions for use
4. Catalog number
5. Serial number
6. Lot number
7. Manufacture date

Symbol Explanation:

| Temperature Limits
---|---
| Humidity
| Atmospheric Pressure
| Waste Symbol
| Caution
| Non-ionizing Radiation Symbol
| Laser Radiation
| Follow Instructions for use

Warnings and Precautions

Before using the Multi Radiance Laser device, the operator should become acquainted with the operating procedures, as well as the indications, contraindications, warnings and precautions. Consult other resources for additional information regarding the benefits and limitations of Multi Radiance therapy. It is important to keep this guide handy and it should be studied and reviewed periodically by users.

Warnings
Please follow these warnings as they will help prevent damage to the device and avoid possible injuries.

• Do not look directly at the light source. Direct or reflected radiation should be prevented from entering the eyes. Use only supplied protective eyewear.
• The device may cause malfunction if used in the vicinity of a pacemaker.
• During treatment, avoid direct exposure of the treated area to other intense light sources such as a UV Sun Lamp.
• Do not exceed the treatment duration and frequency recommended in the operating instructions.
• Do not allow the unit to contact broken skin. The device is not sterile and may cause infection.
• Keep the device away from children, especially the power adapter cord (to prevent strangulation).
• Do not use around water. Contact with water could cause electric shock.
• This device is NOT waterproof so do not immerse in liquids.
• For external use only.
• Don’t use flammable materials near the device.
• Use only the accessories provided with this device including the power adapter.
• This device has been tested for and passed testing for biological compatibility. However, if you are hypersensitive, proceed with caution using this device by testing for adverse reactions to the device materials.

Precautions

• Use this device only as directed.
• Keep clean, far from an open flame and other heat sources such as a fireplace or radiant heater
• Do not use if the device is damaged in any way.
• Do not use if the device is exposed to excessive moisture or becomes wet.
• Should only be maintained and serviced by Multi Radiance Medical personnel or other qualified personnel approved in writing by Multi Radiance Medical.
• Do not drop in order to protect the device against mechanical damage.
• Use of controls, adjustments, performance or procedures other than those specified in this manual may result in less effective outcomes.
• Do not position device to make it difficult to disconnect device
• Do not disconnect by pulling the cord itself.
• The function of this device may be compromised when used close to strong electromagnetic fields. See EMC section for more details.
• Replacement of lithium battery by inadequately trained personnel could result in a hazardous situation

Indications and Contraindications

Indications for Use
In the United States, Multi Radiance Medical devices are cleared by the Food and Drug Administration (FDA) for the following indication of use:

• Temporary relief of minor muscle pain
• Temporary relief of joint pain
• Temporary relief of arthritis
• Temporary relief of muscle spasm
• Relieving stiffness and promoting relaxation of muscle tissue
• Temporarily increasing local blood circulation where heat is indicated

Contraindications
Do not treat or use:

Directly into the eyes – It is universally well known that lasers can cause eye damage. Even though the emitter has a laser safety classification of 1 (very safe), Multi Radiance Medical has decided to be cautious and recommend the laser not be used directly in or near the eyes.
Pregnancy – Light therapy is not to be used to treat pregnant patients.
Carcinoma – Light therapy is not to be used on patients diagnosed with cancer.
Fever – Normally caused by a systemic issue that may be amplified with the use of a laser due to increased blood flow. Proper protocol would be to ensure the fever has subsided before starting laser treatments.
Over hemorrhages – Including persons who are at risk of hemorrhage following acute trauma or fracture or may have acute occult bleeding (gastric ulcer, intestine).
Normally there is already increased blood flow with these conditions. Light therapy or electrical stimulation therapy may exacerbate the situation.
In the vicinity of a pacemaker – Pacemakers are encased in metal and cannot be infl uenced by photons. Any device that also uses a magnetic field should not be used within the vicinity of a pacemaker as the magnet may cause interference with the pacemaker. Manufacturers of pacemakers contraindicate magnetic fields.

Primary and Secondary Considerations

Considerations should not be confused with contraindications. Through years of research, clinical experience and anecdotal evidence, a number of factors have been shown to affect the outcomes of Multi Radiance therapy. However this does not indicate a true contraindication for Multi Radiance therapy’s use.
Research shows that the use of anti-inflammatory medications, both oral and inject­ able, block the effect of Multi Radiance Medical therapy.
Contraindications are clearly defined as being adverse or to produce ill effects within the patient. These considerations have not been shown in published research to exist. Again, what we list are not contraindications per se, nor are they considered harmful, but the clinician should take them into account before prescribing Multi Radiance therapy.

Primary Considerations

• Oral anti-inflammatory medications
• Over recent steroid injections (1-2 weeks post)
• Botox injection sites
• Photosensitive patients

The Secondary Considerations category describes various techniques that should be applied when working with particular patient conditions. The use of Multi Radiance therapy will have better outcomes if the following considerations are taken into account before initiating treatment at these sites.

Secondary Considerations

• Anticoagulants: Do not use direct contact methods
• Chronic musculoskeletal localized inflammation: Patients with chronic condition that are treated with Multi Radiance Laser may react negatively initially. Treatments should be kept relatively short.

Operating lnstrudions & Pre-Programmed Mode Buttons

1. Disconnect the TQ Solo from the AC power adapter.

2. Turn on the TQ Solo by pressing and holding the START/STOP button (1 sec). You will hear two beeps and depending on the configuration of the green LED indicators the TQ Solo may be ready to perform a Self-Test or ready for Normal Use See section 3 for Self-Test or section 4 for Normal Use

3. Self-Test
   • Four constantly on green LED indicators means the TQ Solo is ready for a self-test to ensure proper operation. The four green LED indicators are the Treatment, SHz, S0Hz and the Variable. Please note the Self-Test must be performed before the TQ Solo can be used.
   To administer the Self-Test perform the following steps.
   • Place device’s aperture over the palm of your hand and press START/STOP button to begin test. Note: A built-in safety feature will prevent the device from operating without the emitter aperture being placed fully on the skin.
   • If self-test is successful two green indicator lights will stay illuminated (Treatment and 5 Hz) and device is ready to work.
   • If all three mode indicator lights blink and you hear a beeping from the device, it means that self-test is failed. Press the START/STOP button once to clear the alarm. Self-test procedure may be repeated making sure that emitters aperture being placed fully on the skin. If self-test continues to fail, contact the manufacturer.

4.  Normal Use
   • The SHz green LED indicator will constantly be on.
   • Use the Mode button to select between settings of 5 Hz, 50 Hz, or Variable.
   • Place and hold the TQ Solo with the light aperture against the area to be treated. Be sure to hold the emitter flat against the skin for the duration of the treatment.
   • Push the START/STOP button to begin the treatment session. The Treatment indicator light will start flashing.
   • At the conclusion of the treatment, the treatment indicator light will stop flashing and a short beep is heard. Select another program via the Mode button, or push the START/ STOP button to repeat the treatment.
   • To stop a treatment at any time, push the START/STOP button.
   • To power off the TQ Solo, press and hold the START/STOP button for 3 seconds, the device will then beep and power off.
   • If device is not being used, it will switch itself off after 1 minute of inactivity to preserve battery charge.

Pre-programmed Mode Buttons

Methods of Providing Treatment and Troubleshooting

Methods of Providing Treatment

1. Where possible, treatment should be provided on bare skin.
2. In general, the emitter should simply be held in the place where the pain or discomfort is being felt.
3. In cases where the area of treatment is more general, the emitter may be moved (scanned) around the painful area.

Treatment can be provided over clothing or over wound dressing. Where possible, clothing should be removed or kept to a minimum, as this can reduce the ability of the laser to penetrate, as well as altering the distance between the emitter and the area being treated, which will change the penetration depth.

Troubleshooting

battery charging the
battery light is not green then the device must be repaired
All 3 program lights are blinking| The TQ Solo has failed its self test| Press START/STOP button to reset the device. If this
does not work, the device must be repaired

Maintenance

Cleaning Instructions:

• Only simple surface cleaning is recommended.
• Ensure the device is unplugged from an electrical outlet.
• Wipe with a soft-non-fibrous cloth moistened with a solution composed of 2 parts water to 1 part alcohol.
• If a disinfectant must be used in the case of infectious disease, ensure that disinfectant has been removed by wiping again with clorox healthcare wipes.
• If necessary use a FDA approved disinfectant according to the manufactures instructions.
• After cleaning, wipe the device dry with a soft cloth and leave it on a clean surface to dry.
• Ensure the parts are dry prior to use.

CAUTION DAMAGE MAY OCCUR IF YOU:

• Apply any liquid cleaner or disinfectant directly to the device.
• Allow the device to become wet or submerged in liquid.
• Use an abrasive cleanser.
• Use volatile solvents (toluene, butyl alcohol, denatured ethanol, acetone).
• Use solutions of more than 70% alcohol on the device.
• Use soiled or gritty cloths.
• Use compressed air.
• Clean the connections or connectors with any liquids.
• Sterilized by any liquid or autoclave method. (Do not sterilize damage WILL occur)
• Expose the device to extreme temperatures, humidity, or direct sunlight.

Multi Radiance Medical products should not be disposed of with general household waste. Please dispose of according to local regulations.

Ongoing Maintenance
The device should be checked regularly to determine that it functions normally and to ensure there is no external damage other than normal wear and tear. The radiant surface should be checked before each use to ensure that it is not cracked and does not contain any foreign materials. If during these inspections, you identify an area of concern, please contact the manufacturer to determine if action is required.
Technical Maintenance
No attempt should be made to disassemble the device. Only authorized personnel should complete maintenance and repairs. The manufacturer will not be held responsible for the results of maintenance or repairs by unauthorized persons.
Warning: No modification of this equipment is allowed

Electromagnetic Compatibility (EMC)

The TQ Solo is intended for use in the electromagnetic environment specified below.
The customer or the user of the TQ Solo should assure that it is used in such an environment.
The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally required) this equipment might not offer adequate protection to radio-frequency communication services. The user might need to take mitigation measures, such as relocating or re-orienting the equipment.
WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
WARNING: Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.
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 TQ Solo, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

The TQ Solo complies with the following:

• IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard:
  Electromagnetic compatibility – Requirements and tests

• CISPR 11 :201 S+A 1 2016 – Group 1, Class A

• IEC 61000-4-2:2008 -±8 kV contact, ±15 kV air

• IEC 61000-4-3:2010- 3 V/m 80 MHz to 2,7 GHz
  Deviations to the Radiated Immunity test: Due to the size of the EUT and engineering rationale, only two sides of the EUT were tested.

• IEC 61000-4-8:2009-3 Alm

Warranty Certificate and Guarantee Statement

The product you have purchased is under warranty by Multi Radiance Medical against defects in materials or workmanship for 24 months from date of purchase. If this product is determined to be defective, Multi Radiance Medical will repair or replace it, at its discretion, at no charge during the warranty period.
After the warranty period, the user must pay for all parts and labor charges. If product is repaired or replaced, either within or outside the warranty period, Multi Radiance Medical reserves the right to provide equivalent parts in different colors to your original product. This warranty does not cover damages caused by the acts of God, misuse, negligence, accident, modification of, or to any part of the product. This warranty does not cover damage due to improper operation or maintenance, connection to improper voltage supply, or attempted repair by anyone other than authorized Multi Radiance Medical personnel. This warranty is void if product is tampered with.
To obtain warranty service, customer must contact us at 1-800-373-0955 to obtain a return authorization number. Packages without return authorization will be refused. Customer must deliver the product freight prepaid, in either its original packaging or packaging affording an equal degree of protection, together with customer name, address and return authorization number to:

c/o Multi Radiance Medical Inc.
6521 Davis Industrial Parkway
Solon, OH 44139 USA
Toll Free: 1-800-373-0955
ph. +1-440-542-0761
Fax +1-440-542-0765
Limitation of Liability; Indemnity: Except as expressly set forth above, Multi Radiance Medical shall not be liable for any special, indirect, or consequential damages that are directly or indirectly related to the use of, or the inability to use the device even if Multi
Radiance Medical has been advised of the possibility of such damages whether in an action of contract, negligence or other tortuous action. Some states do not allow the exclusion or limitation of incidental or consequential damages, so the above limitation exclusion may not apply to you. Manufacturer’s liability shall not exceed the purchase price or $250, whichever is greater.
Governing Law: The usage of the Multi Radiance device and the interpretation of its terms shall be governed and construed in accordance with the laws of the State of Ohio, applicable to agreements negotiated, executed and performed wholly and solely within the State of Ohio. The parties agree that the State of Ohio conflicts of laws rules shall not apply to this Agreement or any transaction performed by or under this Agreement.
Jurisdiction and Venue: The parties irrevocably submit and consent to the sole and exclusive jurisdiction and venue of the Ohio State courts in and for Cuyahoga County, Ohio, USA. The parties agree not to raise the defense of forum non-conveniens.

www.multiradiance.com
©2022 Multi Radiance Medical®. All rights reserved.
D-M800-300U5A

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