Empi phoenix User Manual
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Empi phoenix User Manual

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Empi
™
CONDUCTIVE GARMENT
USER'S MANUAL
• Read carefully before using this Garment
• Visit www.djoglobal.com

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  • Page 1 Empi ™ CONDUCTIVE GARMENT USER’S MANUAL • Read carefully before using this Garment • Visit www.djoglobal.com...

  • Page 2: Table Of Contents

    The garment provides a conductive pathway between the Phoenix device and the Phoenix Garment Electrodes. This Garment is only to be used with the Phoenix device’s NMES P1 and P2 programs (“Endurance” and “Strength” respectively for the USA, “Disuse Atrophy” and “Reinforcement”...

  • Page 3: Glossary Of Symbols

    This Garment is intended for use with Empi Phoenix device indoors in a seated position at home or in a clinic environment. Follow your health care provider’s directions for more specific use instructions. Glossary of Symbols This device may contain one or more of the following symbols:...

  • Page 4: Garment Use

    2. Remove the blue plastic lining from the grid side of Phoenix Garment Electrodes and discard. 3. Press the grid side of the Phoenix Garment Electrodes over the silver buttons within the appropriate outlines. If you are using the garment to treat your right leg, place the electrodes in the grey outlines marked with “Right Leg Electrode...
  • Page 5 6. Place the wrap over your thigh with the Empi logo facing you and centered on your thigh. The far edge of the garment should be just above your kneecap. The underside of the garment also indicates the proper orientation of the garment in relation to your knee.

  • Page 6: Storage

    Storage • Gently remove the garment. The Phoenix Garment Electrodes will lift off of your skin and stay attached to the wrap. Electrodes should remain on wrap for storage. If the electrodes remain on your skin instead of the garment, remove them from your skin and place them back on the garment in the appropriate location.

  • Page 7: Warranty

    90 Day Warranty Empi will repair or replace, at its facility, any product found to be defective within 90 days of purchase. This warranty does not apply to any product damaged by misuse, or repaired or altered by anyone other than Empi in Clear Lake, SD, or an officially approved DJO Global service center.
  • Page 8 Manufactured in Mexico for: Empi, Inc. EU Authorised Representative 205 Hwy 22 East MDSS GmbH Clear Lake, SD 57226 USA Schiffgraben 41 +1 651 415 9000 30175 Hannover 360412, Rev. C © 2014 Empi Germany...

  • Page 9: User's Manual (360413 For Usa, 360425 For International)

    Empi ™ COMPLETE ELECTROTHERAPY SYSTEM USER’S MANUAL • Read this manual carefully before operating the Phoenix™ • Visit us at www.djoglobal.com...
  • Page 10 6.4 Electrode Positions ....... . . 15 6.4.1 Use of the Empi Phoenix Thigh Garment ....15 6.5 Stimulation Positions .
  • Page 11 16. Quick Start Guide ........39 Phoenix User’s Manual...

  • Page 12: Foreword

    The device can be paired with the Empi Phoenix Conductive Garment for the thigh, which is designed to make treatment of the knee/quadriceps with NMES easier for the patient and clinician.

  • Page 13: Intended Use

    • Maintenance of increase of range of motion 2.2 Use Environment The Empi Phoenix device is a prescription device in the USA and is intended to be used following the directions of a healthcare provider. The device should be used indoors and may be used in a healthcare facility setting or by a patient or lay operator in a home environment.

  • Page 14: Explanation Of Symbols

    US and Canadian product safety standards. This device Conforms to AAMI Std. ES60601-1. Certified to CAN/CSA Std. C22.2#60601-1. 9900900 Manufacturing year Manufacturer name and address Power/Pause Dangerous voltage Lead wires comply with the Performance Standard for electrode lead wires (21 CFR part 898) Phoenix User’s Manual...

  • Page 15: Safety Information

    TENS for undiagnosed pain. Do not use the Empi Phoenix device as a TENS device (P3) on patients whose pain syndromes are undiagnosed.

  • Page 16: Precautions

    Power supply. Never connect stimulation cables to an external power supply as there is a risk of electric shock. Near other equipment. Do not use the Empi Phoenix device beside or stacked on top of any other equipment. If you must use it side by side or on top of another system, you should check that the Empi Phoenix device works properly in the chosen configuration.
  • Page 17 Empi Phoenix device and the battery compartment. Garment. Do not use the Empi Phoenix Thigh Garment in proximity of fire or excessive heat sources due to the risk of fire. Make sure that the electrodes cover the metal connectors on the Phoenix garment before use to avoid shocking, skin irritation, and burns.

  • Page 18: Dangers

    Electrodes. Any Empi Electrode with a minimum active area of 16 cm may be used with this device. This includes Empi 2” round and 2” square StimCare electrodes. Use of an electrode with an area less than 16 cm can cause burns when the unit is used at higher intensities.

  • Page 19: How Does Electrotherapy Work

    In other words, the muscle cannot distinguish whether the command comes from the brain or from the stimulator. The parameters of the Empi Phoenix programs (number of pulses per second, contraction time, rest time, total program time) subject the muscles to different types of work.

  • Page 20: Usage Guidelines

    Empi Phoenix device. 6.1.1 Endurance – P1 The Empi Phoenix Endurance program focuses on generating a medium muscle contraction. This working level is maintained over a long time period (20 minutes per session). The Endurance program specifically activates the aerobic metabolism of the fibers during the stimulation session.

  • Page 21: Strength - P2

    3 Hz 6.1.2 Strength – P2 The Empi Phoenix Strength program imposes a high and instantaneous power working level on muscle fibers. These contractions are separated by long periods of rest. The result is an average medium power working level (+ 20 minutes). This program is intended to increase the maximum strength of muscle isometric contraction.

  • Page 22: Modulated Tens - P3

    The choice of a program is determined by your clinician based on the affected body part(s). The appropriate muscle stimulation program(s) (e.g., Strength, Endurance, TENS or Edema) and frequency of the program(s) are determined by your clinician. Consult your Clinician or therapist if you are unsure which program to use. Phoenix User’s Manual...

  • Page 23: Planning Of Stimulation Sessions

    6.3. Planning of Stimulation Sessions Your clinician will instruct you on a protocol (intensity, electrode placement, number of times per day and per week) to follow in order to use the Empi Phoenix device most effectively. 6.4 Electrode Positions For optimal results, use the electrode positions recommended by your medical professional.

  • Page 24: Stimulation Positions

    Unless you have instructions from your clinician otherwise, you should increase the intensity of the Endurance (P1) and Strength (P2) programs until you get a strong muscle contraction. Please follow the Safety Information advice in Section 4 to avoid injury. Phoenix User’s Manual...

  • Page 25: Operating Instructions

    H. Channel 2 output connector Remote switch input connector (hand switch is an optional accessory) J. Belt Clip (removable) K. Battery door to access the battery compartment. A label describing the programs is affixed to the battery door. Phoenix User’s Manual...

  • Page 26: Kit Composition And Accessories Description

    199696 235684 199327-001 193057-100 199695 Accessory Part Number Quantity Description STANDARD INCLUSIONS – PHOENIX DEVICE Unit 199696 One Phoenix device 193057-100 Package of one leadwire Lead wires (40” long) assembly with red and black pins Package of four carbon cloth...

  • Page 27: Preparation

    6. Dispose of the old batteries in accordance with local and national regulations. 3. Place the batteries Remove the batteries from the Empi Phoenix as indicated on the device if it is not used for a prolonged period bottom of the battery of time (e.g.

  • Page 28: Placement And Care Of The Electrodes

    Pay attention to the polarity shown in Section 6.4 and the indications given in Section 2.1. 7.3.5 Use of the Empi Phoenix Thigh Garment Device (optional) Please refer to the Empi Phoenix Thigh Garment User Manual for proper use. Phoenix User’s Manual...

  • Page 29: Operation Of The Device

    7.4 Operation of the Device 7.4.1 LCD display The Empi Phoenix device is equipped with a Liquid Crystal Display (LCD) to make the User Interface easy to use and understand, and to provide clear information about the on-going treatment. The following picture depicts the complete LCD with all its symbols. Intensity Display, Intensity Bar Graph, and Open Circuit Icon are on the left for Channel 1 and on the right for Channel 2.

  • Page 30: Pause Function

    • In a constant mode (P3, P4, warm up and cool down of P1 and P2), pushing the button will activate the stimulation while releasing it will bring all intensities to 0. • In Work mode, pushing and releasing the button, respectively, will toggle between contraction and active-rest phases. Phoenix User’s Manual...

  • Page 31: Meaning Of Indicators

    When the electric circuit is interrupted, the intensity drops to 0 and the program is paused. In this case check whether the electrode lead wire is correctly connected to the device and whether the electrodes are properly connected. Phoenix User’s Manual...

  • Page 32: Troubleshooting

    8. Troubleshooting If an error screen appears while you are using the device, write down the error code displayed and contact Empi’s Repair Department at 800.862.2343. Possible Problem Solution cause A. Make sure the batteries are properly installed. (Check polarity markings).
  • Page 33 Refer to section 6.1 for a description of the Programs. Stimulation is A. Check that all the settings are correct and ensure the electrodes Settings and not producing are positioned properly. Electrodes the usual positioning B. Change the positioning of the electrodes slightly. sensation Phoenix User’s Manual...

  • Page 34: Device Maintenance

    9.2 Cleaning and Calibration Clean using a damp cloth or soft cloth and an alcohol based, solvent-free cleaning product. Use only a minimum amount of liquid when cleaning the Empi Phoenix device. Allow the Empi Phoenix device to completely dry before use.

  • Page 35: Repair

    9.6 Expected Life and Disposal The Empi Phoenix device is expected to provide at least seven years of normal use. If you are renting the Empi Phoenix device, please return it to Empi when you no longer need it for therapy.

  • Page 36: Clinician Only Section

    11.1 Compliance Monitoring The Empi Phoenix device is equipped with a compliance monitoring system. This allows you to monitor the usage of the device by your patient between visits. To access the compliance screen, simultaneously and...

  • Page 37: Program Lock

    Right Decrease buttons until the Program Lock symbol disappears. 11.3 Ordering Information for Clinicians To order the Empi Phoenix device for your patients, contact either your local Empi/DJO Global representative or Empi Clinic Services at 800.325.5663. Phoenix User’s Manual...

  • Page 38: Limited Warranty

    12. Limited Warranty Warning While, in the opinion of Empi, Inc. the use of the Empi Phoenix (“the Product”) has met with some success, Empi, Inc. makes no warranties to the purchaser as to the effectiveness of the product. Warranty A.
  • Page 39 D. Empi, Inc. shall not be liable to any person for any direct, indirect, special, incidental or consequential damages, lost profits or medical expenses caused by any defect, failure, malfunction or otherwise of the product, regardless of the form in which any legal or equitable action may be brought against Empi, Inc.

  • Page 40: Technical Specifications

    Pulse Width and current measured as shown across 1kOhm loads. These measurements are also valid on a 500 Ohm load, as the Phoenix is a current controlled device. Any load between 500 Ohms and 1 kOhm will not affect the output measurements.
  • Page 41 • Type BF Applied Part • Internally powered only • Protection against ingress of particles and liquids: • Continuous operation • Not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide. Phoenix User’s Manual...

  • Page 42: Guidance And Manufacturer's Declaration - Electromagnetic Emissions

    Empi Phoenix device. • Warning: The Empi Phoenix device should not be used beside or stacked on top of any other equipment. If you must use it side by side or on top of another system, you should check that the Empi Phoenix device works properly in the chosen configuration.
  • Page 43 GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY Empi Phoenix is intended for use in the electromagnetic environment specified below. The customer or user of the Empi Phoenix should assure that it is used in such an environment Test level IEC Compliance...
  • Page 44 GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY The Empi Phoenix is intended for use in the electromagnetic environment specified below. The customer or the user of the Empi Phoenix should assure that it is used in such an environment. IEC 60601 test...
  • Page 45 PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE EMPI PHOENIX The Empi Phoenix is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Empi Phoenix can help prevent electromagnetic interference by maintaining a minimum distance between...

  • Page 46: Additional Information On Electrode Placement For Knee Treatment

    Knee Rehabilitation In the absence of direction from a clinician on electrode placement, use the following electrode placement guidelines for knee rehabilitation if using the Empi Phoenix device with direct leadwires and not with the Empi Phoenix Thigh Garment. NMES Programs – P1 (Endurance) and P2 (Strength): 1.

  • Page 47: Quick Start Guide

    Warm Up. Once the Work Phase begins you can adjust the intensity further. P1 and P2 finish with a Cool Down phase. Refer to the Section 6.1 of this manual for a full explanation of these programs. Phoenix User’s Manual...
  • Page 48 199696 Phoenix Kit Empi, Inc. 205 Hwy 22 East Clear Lake, SD 57226 USA 651.415.9000; 800.328.2536 360413 Rev. A © 2013 Empi, Inc. 04/13...

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