1. Manuals
  2. Brands
  3. BIOFLEX Manuals
  4. Medical Equipment
  5. Arthritis
  6. Manual

BIOFLEX Arthritis Manual

Hide thumbs
Table of Contents

Advertisement

Quick Links

Download this manual
BIOFLEX
Arthritis
®
www.bioflexlaser.com

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the Arthritis and is the answer not in the manual?

Questions and answers

Subscribe to Our Youtube Channel

Related Manuals for BIOFLEX Arthritis

Summary of Contents for BIOFLEX Arthritis

  • Page 1 BIOFLEX Arthritis ® www.bioflexlaser.com...
  • Page 2 All brand and product names mentioned are used for identification purposes only and are trademarks or registered trademarks of their respective holders. BIOFLEX Arthritis System User Manual ® Date of issue: – Jan 26, 2022 MN421.018 Rev 3...

  • Page 3: Table Of Contents

    Conditions Treated and Placement of Array What’s In The Box Connecting The System Application Of Treatment Important Information System Troubleshooting System Specifications Safety Standards Maintenance and Repair Electromagnetic Compatibility (EMC) BIOFLEX Arthritis System Parts List ® Notes MN421.018 Rev 3...

  • Page 4: Introduction

    The system can be easily applied at home, while traveling or otherwise engaged. The unit is a highly sophisticated derivative product of the BIOFLEX Series ®...

  • Page 5: System Basics

    Red and Infrared light therapy to arthritic joints. Research-based protocols have been developed for the most common joints affected by arthritis. Four protocol stages are available to treat each area. The Treatment Array’s soft, flexible composition readily adjusts to the configurations of the anatomical area to which it is applied.

  • Page 6: Planning Your Treatments

    Planning Your Treatments For most arthritic conditions, your treatments can take anywhere from 30 minutes to an hour, therefore we recommend finding a comfortable location and plan something relaxing while the treatment is ongoing. Placement of the Array Light therapy is most effective when the Treatment Array is placed firmly on the skin and directly over the arthritic joint (focal point of the pain).
  • Page 7 Additional Instructions • All areas are treated with the application of the Array, which delivers Red light initially, followed sequentially by the Infrared automatically. • Following the initial placement (please see diagrams) and initiation of the treatment protocol, the first placement will end as indicated by 3 consecutive beeps.

  • Page 8: Essential Performance

    RISK. The Essential Performance of the BIOFLEX ® Arthritis system according to IEC 60601-1 Ed. 3.1, is to not radiate harmful levels of light to shine in the eyes of the patients, operators or bystanders. Side Effects The following may be experienced: pain;...

  • Page 9: Conditions Treated And Placement Of Array

    Placement of Array Intended Use The BIOFLEX Arthritis system is used by patients as well as trained health ® care professionals and is indicated for use to emit energy in the red and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of arthritic pain.
  • Page 10 Temporomandibular Joint Dysfunction Pain (TMJ) Placements • Red outline indicates placement of Array. • Ensure firm contact of the Array on bare skin. • Secure the Array using provided straps or small weight • Treat around the entire arthritic joint using as many placements as required (refer to illustrations below).
  • Page 11 Shoulder Pain Placements • Red outline indicates placement of Array. • Ensure firm contact of the Array on bare skin. • Secure the Array using provided straps or small weight • Once the Array cycles through RED and INFRARED light, re-position to the next placement and start treatment again.
  • Page 12 Elbow Pain Placements • Red outline indicates placement of Array. • Ensure firm contact of the Array on bare skin. • Secure the Array using provided straps or small weight • Once the Array cycles through RED and INFRARED light, re-position to the next placement and start treatment again.
  • Page 13 Wrist Pain Placements • Red outline indicates placement of Array. • Ensure firm contact of the Array on bare skin. • Secure the Array using provided straps or small weight • Once the Array cycles through RED and INFRARED light, re-position to the next placement and start treatment again.
  • Page 14 Hand Pain Placements • Red outline indicates placement of Array. • Ensure firm contact of the Array on bare skin. • Secure the Array using provided straps or small weight • Once the Array cycles through RED and INFRARED light, re-position to the next placement and start treatment again.
  • Page 15 Foot Pain Placements • Red outline indicates placement of Array. • Ensure firm contact of the Array on bare skin. • Secure the Array using provided straps or small weight • Once the Array cycles through RED and INFRARED light, re-position to the next placement and start treatment again.
  • Page 16 Ankle Pain Placements • Red outline indicates placement of Array. • Ensure firm contact of the Array on bare skin. • Secure the Array using provided straps or small weight • Once the Array cycles through RED and INFRARED light, re-position to the next placement and start treatment again.
  • Page 17 Cervical Spine Pain (Neck) Placements • Red outline indicates placement of Array. • Ensure firm contact of the Array on bare skin. • Secure the Array using provided straps or small weight • Once the Array cycles through RED and INFRARED light, re-position to the next placement and start treatment again.
  • Page 18 Thoracic Spine Pain (Upper Back) Placements • Red outline indicates placement of Array. • Ensure firm contact of the Array on bare skin. • Secure the Array using provided straps or small weight • Once the Array cycles through RED and INFRARED light, re-position to the next placement and start treatment again.
  • Page 19 Lumbar Spine Pain (Lower Back) Placements • Red outline indicates placement of Array. • Ensure firm contact of the Array on bare skin. • Secure the Array using provided straps or small weight • Once the Array cycles through RED and INFRARED light, re-position to the next placement and start treatment again.
  • Page 20 Hip Pain Placements • Red outline indicates placement of Array. • Ensure firm contact of the Array on bare skin. • Secure the Array using provided straps or small weight • Once the Array cycles through RED and INFRARED light, re-position to the next placement and start treatment again.
  • Page 21 Knee Pain Placements • Red outline indicates placement of Array. • Ensure firm contact of the Array on bare skin. • Secure the Array using provided straps or small weight • Once the Array cycles through RED and INFRARED light, re-position to the next placement and start treatment again.

  • Page 22: What's In The Box

    What’s In The Box When you receive your BIOFLEX Arthritis system, check to make certain ® that all of the parts shown below are included and undamaged. If parts are missing or damaged, contact Meditech service at 1-844-770-0177 or service@bioflexlaser.com...

  • Page 23: Connecting The System

    Connecting The System This is as easy as 1-2-3: 1. Connect the power cord, AC/DC adapter and Controller as shown 2. Connect the Controller Unit to AC/DC adapter MN421.018 Rev 3...
  • Page 24 3. Connect Treatment Array to Controller Unit, by inserting the treatment array connector until you hear an audible click. To remove, squeeze the sides and pull. Your fully connected system should appear as demonstrated below. MN421.018 Rev 3...
  • Page 25 Neck Upper Back Shoulder Lower Back Elbow Hand Wrist Knee Foot Ankle Treatment Stage Timer Power Stop Start/ Select Button Pause Stage Strap Anchor Points Treatment LEDs Power LED Top View of Treatment Array Bottom View of Treatment Array MN421.018 Rev 3...

  • Page 26: Application Of Treatment

    Press the circle on the Controller Unit that corresponds to the area of the body to be treated (e.g., face, knee, etc.). When selected, the circle will turn blue. Step 4 The Treatment Stage of the BIOFLEX Arthritis system ® automatically selects Stage 1 (recommended for at least the first five treatments or longer).

  • Page 27: Important Information

    The device is to be used in a dry environment only and must be kept dry at all times. • In the event of changes in the performance of the BIOFLEX Arthritis ® system, stop using the device immediately. Contact Meditech service department for further instructions.
  • Page 28 15 minutes before it is used again. • The BIOFLEX Arthritis system is intended to be used externally, over ® the skin only. Do not treat over mucous membranes or over the eyes. It is inappropriate to shine the light emanating from the Treatment Array into the eyes.

  • Page 29: System Troubleshooting

    System Troubleshooting This section summarizes the most common problems encountered with the BIOFLEX Arthritis system. If you are unable to solve the problem with ® the information below, contact Meditech Service at 1-844-770-0177. Problem Possible Cause Solution Part or all of the...
  • Page 30 Issue Possible Cause Solution No power or The power supply Plug the power supply display is blank. is not connected. into a wall outlet. Power is not Ensure the cable is turned on. plugged into the Controller Unit. The Unit will beep once the power is connected.

  • Page 31: System Specifications

    System Specifications Electrical Specifications Rated voltage 100-240V Rated frequency 50-60 Hz Operating Conditions Temperature +5°C (41°F) to +25°C (77°F) Relative humidity 15% to 93% (non-condensing) Atmospheric pressure 700hPa to 1,060hPa Storage and Transport Conditions Temperature / humidity -25°C (-13°F) without relative humidity control +70°C (158°F) at a relative humidity up to 93%, non-condensing...

  • Page 32: Safety Standards

    Safety Standards This product is classified as medical equipment and has been tested to comply for the following standards: Compliances General Basic Safety: • IEC 60601-1:2012, (3.1 Edition). Canada and USA national deviations: • CAN/CSA C22.2 No. 60601-1:2014, 3.1 • ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/ (R)2012 and A2:2010/(R)2012 (also referred to as ANSI/AAMI ES60601-1:2005/(R)2012)
  • Page 33 Warning Symbols and Labels Consult User Manual Refer to the User Manual instructions. TYPE BF APPLIED PART This product is classified as a Type BF Applied Part, according to the degree of protection against electric shock. Waste Electrical and Electronic Equipment Directive This symbol indicates that the waste of electrical and electronic equipment must not be disposed...

  • Page 34: Maintenance And Repair

    Maintenance and Repair Warning: Do not modify this equipment without Meditech’s authorization. If the BIOFLEX Arthritis system gives repeated errors it might need ® repair. Please contact Meditech or one of its authorized representatives for repair services. Attention: Only Meditech authorized service personnel may service or repair the system.

  • Page 35: Electromagnetic Compatibility (Emc)

    Portable and mobile RF communications equipment can affect Medical Electrical Equipment. Warning: The BIOFLEX Arthritis system is intended for use by general ® public. It is suitable for use in all establishments including domestic establishments and those directly connected to the public low-voltage...
  • Page 36 Warning: The BIOFLEX Arthritis system should not be used adjacent to or ® stacked with other equipment and that if adjacent or stacked use is necessary, the equipment should be observed to verify normal operation in the configuration in which it will be used.
  • Page 37 Table 3 – Immunity Test Level Compliance The BIOFLEX Arthritis system is intended for use in the electromagnetic environment ® specified below. The customer or the user of the BIOFLEX Arthritis system should assure ® that it is used in such an environment.
  • Page 38 Table 4 – Immunity Test Level Compliance The BIOFLEX Arthritis system is intended for use in the electromagnetic environment ® specified below. The customer or the user of the BIOFLEX Arthritis system should assure ® that it is used in such an environment.
  • Page 39 The BIOFLEX Arthritis system is intended for use in an electromagnetic environment in ® which radiated RF disturbances are controlled. The customer or the user of the BIOFLEX ® Arthritis system can help prevent electromagnetic interference by maintaining a minimum...

  • Page 40: Bioflex ® Arthritis System Parts List

    BIOFLEX Arthritis System Parts List ® Components Part No. Controller Unit DW100.785-06 Treatment Array DW400.011-02 Carrying Case CT402.009 User Manual MN421.018 Power Supply CT402.006 Power Cord (North America) CT402.019 Glasses (Optional) CT402.016 Power cord part number may vary based on region/country the system is shipped to.

  • Page 41: Notes

    Notes MN421.018 Rev 3...
  • Page 42 Notes MN421.018 Rev 3...
  • Page 43 Notes MN421.018 Rev 3...
  • Page 44 411 Horner Ave Unit 1 TollFree.1-844-770-0177 Toronto, ON, CAN info@bioflexlaser.com M8W 4W3 www.bioflexlaser.com ISO 13485 Meditech International MN421.018 Rev 3 Manufactured by: Meditech International Inc.

Table of Contents