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Canadian Standards

CAN/CSA C22.2 No. 60601.1, Third ed. - Medical Electrical

Equipment - Part 1: General Requirements for Safety

CAN/CSA C22.2 No. 601-1.M90 - Medical Electrical Equipment –

Part 1: General Requirements for Safety

Canadian and United States of America standards UL 60601-1, First

ed. - Medical Electrical Equipment - Part 1: General Requirements

for Safety

International Standards

IEC/EN 60601-1, Second ed. - Medical Electrical Equipment -Part 1:

General Requirements for Safety

ANSI/AAMI ES60601-1:2005 - Medical electrical equipment - Part

1: General requirements for basic safety and essential performance

IEC 60601-1-2 - Medical Electrical Equipment - Part 1: General

Requirements for Safety - 2. Collateral Standard: Electromagnetic

Compatibility -Requirements and Tests

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Содержание BioFlex 120

Страница 1: ...1 User Manual Meditech International Inc CANADA THE BIOFLEX 120 A Personal Therapy System...

Страница 2: ...2...

Страница 3: ...t the prior written consent of Meditech International Inc Every precaution has been taken in the preparation of this publication Meditech assumes no responsibility for errors or omissions Neither is a...

Страница 4: ...System Basics 8 What s In The Box 9 Connecting The System 10 Connecting The System 11 Getting Started 12 Planning Your Treatments 14 Cleaning 28 System Troubleshooting 29 System Specifications 31 Ele...

Страница 5: ...ditech International we view this system as a major advance in the immediate relief of pain and other symptoms Pathologies are resolved as a result of the initiation of a cascade of physiological acti...

Страница 6: ...oft Tissue Sports Injuries Ligament Tendon Tears Muscle Strains Tendonitis Contusions Repetitive Stress Injuries Carpal Tunnel Syndrome Rotator Cuff Injuries Tennis Elbow Arthritic Conditions Degenera...

Страница 7: ...sharp objects as they may puncture it Do not pull kink or pinch the cables Never tightly wrap cables around the Treatment Array Do not drop the system Do not open or modify any part of the system Cho...

Страница 8: ...Stage 1 for at least the initial five treatments and increase to higher settings only as required The Treatment Array s soft flexible material is easy to clean and readily adjusts to the contours of...

Страница 9: ...ts shown below are included and undamaged If parts are missing or damaged contact BioFlex immediately at 1 844 770 0177 or customerservice bioflexpersonal com Note System parts may appear different th...

Страница 10: ...10 Connecting The System This is as easy as 1 2 3 1 Connect the power cord AC adapter and Controller as shown 2 Connect the Controller Unit to AC adapter...

Страница 11: ...e System 3 Connect Treatment Array to Controller Unit Squeezing the sides of the Treatment Array connector together to easily insert and remove Your fully connected system should look like the followi...

Страница 12: ...k Upper Back Lower Back Hip Knee Ankle Treatment Stage Strap Anchor Points Treatment LEDs Face Shoulder Elbow Wrist Hand Foot Timer Top View of Treatment Array Bottom View of Treatment Array Getting S...

Страница 13: ...rcle will turn blue Step 4 The Treatment Stage of the BioFlex 120 automatically defaults to stage 1 recommended for at least the first five treatments Press the button again for stage 2 or 3 if needed...

Страница 14: ...ply the Array over that particular area The treatment may be completed by applying to the opposing area in order to apply therapy from all perspectives applicable to the region There are 12 different...

Страница 15: ...diminish Possible Reactions and Side Effects During the course of treatment the dermis may become erythematous secondary to physiological effects This condition is not harmful and will disappear follo...

Страница 16: ...16 A B Face Common Conditions TMJ Disorder Postherpetic Neuralgia Placements See Figures A and B for the location of the Treatment Array when treating jaw pain...

Страница 17: ...tress Injury Ligament Tendon Tears Frozen Shoulder Arthritis Degenerative Rheumatoid Rotator Cuff Injuries Muscle Strains Tendonitis Contusions Placements See Figures A to C for the location of the Tr...

Страница 18: ...Tennis Elbow Soft Tissue Injuries Arthritis Degenerative Rheumatoid Ligament Tendon Tears Tendonitis Contusions Placements See Figures A to C for the location of the Treatment Array when treating pai...

Страница 19: ...unnel Syndrome Soft Tissue Injuries Ligament Tendon Tears Reflex Sympathetic Dystrophy Arthritis Degenerative Rheumatoid Tendonitis Placements See Figures A and B for the location of the Treatment Arr...

Страница 20: ...ssue Injuries Arthritis Degenerative Rheumatoid Ligament and Tendon Tears Reflex Sympathetic Dystrophy Tendonitis Contusions Placements See Figures A and B for the location of the Treatment Array when...

Страница 21: ...tar Fasciitis Tarsal Tunnel Syndrome Soft Tissue Injuries Atypical Midfoot Fasciitis Tendonitis Ligament Tendon Tears Muscle Strains Contusions Reflex Sympathetic Dystrophy Placements See Figures A to...

Страница 22: ...s Tension Headaches General Neck Pain Disc Herniation Soft Tissue Injuries Arthritis Degenerative Rheumatoid Fibromyalgia Placements See Figures A to D for the location of the Treatment Array when tre...

Страница 23: ...myalgia Chronic Spinal Problems Herniated Disc Muscle Strains Vertebral Radiculopathy Post Herpetic Neuralgia Arthritis Degenerative Rheumatoid Placements See Figures A and B for the location of the T...

Страница 24: ...tis Degenerative Rheumatoid Disc Herniation Muscular Back Pain Fibromyalgia Rotoscoliosis Scoliosis Chronic Spinal Problems Placements See Figures A to D for the location of the Treatment Array when t...

Страница 25: ...mon Conditions General Hip Pain Inflamed Tendons Arthritis Degenerative Rheumatoid Tear of Labrum Placements See Figures A to C for the location of the Treatment Array when treating pain in a hip join...

Страница 26: ...Tears Arthritis Degenerative Rheumatoid Muscle Strains Contusions Tendonitis Reflex Sympathetic Dystrophy Supra Infrapatellar Tendonitis Placements See Figures A to C for the location of the Treatment...

Страница 27: ...rative Rheumatoid Tarsal Tunnel Syndrome Reflex Sympathetic Dystrophy Ligament and Tendon Tears Muscle Strains Contusions Tendonitis Placements See Figures A to D for the location of the Treatment Arr...

Страница 28: ...ohol wipe soft disinfectant or a soft damp cloth Do not immerse or rinse the Treatment Array in water Clean the Controller Unit using a soft damp or disinfectant cloth when needed When dirty wash the...

Страница 29: ...e Solution Part or all of the system becomes damaged and does not work System has been dropped or damaged somehow Check all power connections Make sure all cables are secure and properly connected Pre...

Страница 30: ...em beeps and displays an E02 error The Treatment Array is hot temperature exceeds 48 C due to being covered or running too long In the event that the Treatment Array gets too hot it will shut off unti...

Страница 31: ...midity control 70 C at a relative humidity up to 93 non condensing Classification Sub clause 6 of IEC 60601 1 and Clause 6 of IEC 60601 1 2005 CLASS I EQUIPMENT according to the type of protection aga...

Страница 32: ...First ed Medical Electrical Equipment Part 1 General Requirements for Safety International Standards IEC EN 60601 1 Second ed Medical Electrical Equipment Part 1 General Requirements for Safety ANSI...

Страница 33: ...OF MEDITECH INTERNATIONAL INC IS PROHIBITED SHEET 1 OF 1 SCALE 1 1 WEIGHT REV DWG NO A SIZE DESCRIPTION Meditech International Inc NAME DATE Q A MFG APPR ENG APPR CHECKED DESIGNED FINISH MATERIAL EOM...

Страница 34: ...until the temperature has dropped The Treatment Array needs to be cooled for at least 15 minutes before it is used again CLASS I LED Class I LED This product uses LEDs that under normal use do not po...

Страница 35: ...information provided in this manual The use of accessories and cables other than those specified and sold by the manufacturer may result in increased emissions or decreased immunity of the equipment...

Страница 36: ...Components Part No Controller Unit Personal 120 Treatment Array Carrying Case User Manual Canada User Manual USA Power Supply Power Cord Safety Glasses DW100 785 DW400 004 CT402 009 MN100 794 MN421 00...

Страница 37: ...37 Notes...

Страница 38: ...38 Notes...

Страница 39: ...39 Notes...

Страница 40: ...40 415 Horner Ave Unit 12 Toronto ON CAN M8W 4W3 A12233 ISO 13485 Meditech International Inc Tf 1 844 770 0177 info bioflexpersonal com www bioflexpersonal com...

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