Empi Phoenix Conductive Garment User Manual
Contents
1. Empi PHOENIX CONDUCTIVE GARMENT USER S MANUAL e Read carefully before using this Garment e Visit www djoglobal com Emptr Table of Contents Product Overview 2 2 2 2 2 2 2 2 5 5 5 5 2525 2 Intended Use 2 2 25 2 25 2 2 252 2D5 5 52 25 d Glossary or Symbols ue Exo EE Re Rm eum ACRIOR Elie ue ae EX ecc Ru d 3 Warnings and Precautions 2 s ex 19e B dete 428 RUE e 2 2 ed 3 Garment Use eee lll 4 onec c r 6 Maintenance 2 2 2 25 22D5 2 52 5 2 52 2 Z 25 5 6 Environmental Conditions 2 2 25 5 6 Storage and Transport Conditions 6 Electrode Use 1 ado wm eee we Dd BR EO UE we Hw dns m wo ee amp a 6 Warranty 2 1 lll ll lll esl esses s s ss 7 CIGGINGs 25 44642844 ne woo ee hb 7717 9111 TT 7 IMPORTANT Please read the Empi Phoenix Device User s Manual 360413 for USA 360425 for International before use Product Overview The Empi Phoenix Conductive Garment for the thigh is an accessory to Empi Phoenix device designed to deliver electrical stimulation to muscles to aid with muscle recovery and re education This specialized garment is a light weight breathable fabric that wraps around the thigh and is secured with Velcro The Garment is designed to provide a convenient application of therapy In the USA Federal Law restricts this devi2. ce to sale by or on the order of a physician or other practitioner licensed to use the device Intended Use The Empi Phoenix Conductive Garment is intended for use with the Empi Phoenix device which is indicated for retarding or preventing disuse atrophy maintaining or increasing range of motion and re educating muscles 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 respectively for International 2 Phoenix Garment User Manual 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 e Refer to Instruction Manual Booklet wd Keep Dry T Caution For Prescription Only K ZA eep Away from Sunlight Federal law USA restricts this device T ONLY to sale by or on the order of a physician or licensed practitioner 41 0 F Precautionary Instructions LATEX FREE No Latex 80 6 F 27 C Min and Max storage 5 C temperatures Warnings and Precautions For a full list of relevant contraindications warnings precautions and ad
3. d dry skin prior to use e Store electrodes as indicated above and on electrode packaging e f electrode gel becomes dry adding a few drops of water to each side of the electrode may help restore adhesive gel of electrode Let the electrode rest to regain tack before applying to skin 6 Phoenix Garment User Manual 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 This warranty is in lieu of any or all other warranties expressed or implied No person is authorized to bind Empi to any representative of warranty other than those specifically set forth herein NOTE Warranty period begins with the date of purchase from manufacturer Ordering To reorder call Empi at 800 328 2536 USA Only Empi Phoenix Garment P N 235684 Phoenix Garment Electrode Pack P N 199695 pack of two 4 x2 75 10 x 7 cm and one 6 x3 5 15 x 9 cm Phoenix Garment User Manual 7 SEmpi Manufactured in Mexico for Empi Inc audi 205 Hwy 22 East Clear Lake SD 57226 USA 1 651 415 9000 360412 Rev C 2014 Empi npe EU Authorised Representative MDSS GmbH ochiffgraben 41 301 75 Hannover Germany CE
4. e condition of the skin at the onset of treatment or a reaction to the materials in the electrodes or garment Safety The safety and efficacy of the Empi Phoenix system depend on the proper use and handling of the product and accessories Use only as prescribed Keep out of reach of children Keep away from open flame Use with other devices accessories Use only the Phoenix device that is specially designed for this garment Do not use accessories including electrodes or devices manufactured by other companies on this garment Empi is not responsible for any consequence resulting from using products manufactured by other companies Phoenix Garment User Manual 3 Garment Use 1 Lay the garment flat with the three conductive silver buttons facing up as pictured 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 Placement If you are using the garment to treat your left leg place the electrodes in the white outlines marked with Left Leg Electrode Placement The large electrode should only be placed within the corresponding larger grey white dashed outline IMPORTANT Make sure to place ALL THREE electrodes on the garment before using The e
5. he saved liner on the electrodes Be sure to place the ON side against the Phoenix Garment Electrode surface Store the garment in its original bag until next treatment Re applying the liners folding up after each use and storing the wrap in re sealable bag will prolong the life of the Phoenix Garment Electrodes Maintenance Check the specialized garment before each use for signs of wear and or damage Make sure that the electrodes have good tack so that they will stick well to the skin Replace the Phoenix Garment Electrodes as required See Electrode Use section for Phoenix Garment Electrodes maintenance suggestions When electrodes are no longer useful dispose of them in a receptacle out of the reach of children or pets If needed you may wash the Phoenix Garment See label on wrap for washing instructions Make sure the garment is dry before using it With proper care this garment is designed to have a life of six months Environmental Conditions Operating Conditions e Temperature Range 10 C to 40 C 50 F to 104 F e Atmospheric Pressure Range 50kPA to 106 kPa e Relative Humidity Range 30 to 75 Storage and Transport Conditions e Temperature Range 40 C to 70 C 40 F to 158 F e Atmospheric Pressure Range 50kPA to 106 kPa e Relative Humidity Range 10 to 90 Electrode Use You can extend the use of your Phoenix Garment Electrodes by following these suggestions e Cleanse rinse an
6. lectrodes must completely cover each conductive metal button before use STOP If you are using the garment for your LEFT leg you should have it set up to look like Fig 1 Fig 1 Left If you are using the garment for your RIGHT leg e you should have it set up to look like Fig 2 4 Remove the remaining clear liner from the face of the electrodes and SAVE for re application to Phoenix Garment Electrodes in between uses Fig 2 5 Sit on the edge of a firm stable chair with your Right knee slightly bent and your foot flat on the floor If your clinician instructed you to use the device and garment in a different setting or position follow your clinician s instructions 4 Phoenix Garment User Manual 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 IMPORTANT Do not use this garment on any body part other than the quadriceps thigh T Wrap the two straps underneath and around your thigh and affix the Velcro M on the softer fabric landing strip With the Phoenix Garment Electrodes aligned over your thigh quadriceps muscles gently apply pressure on the top section of the wrap to secure the electrodes against the skin Do not slide or pull the garment to readjust its position while wearing it as the elect
7. rodes may roll up underneath the garment To adjust remove the garment completely and reposition 8 Connect the black plastic leadwire connector to the garment by sliding it onto the port as shown You should hear an audible click 9 Attach the Empi Phoenix device by inserting both black leadwire heads into the ports at the top of the device Press firmly to ensure that the leadwire is fully inserted into the device 10 Begin therapy as directed by your clinician Unless otherwise directed by your healthcare provider you should be seated during therapy You can holster the device in the garment by attaching the device s belt clip and sliding it into A the flat wide strap in the middle section of the pHoen Empi garment on top of your thigh Do not stand up while the device is in place on the garment When your session is complete turn the device off IMPORTANT This Garment is only to be used with the Phoenix device programs P1 and P2 Phoenix device programs P3 and P4 should be used with the direct leadwires and electrodes provided with the device Phoenix Garment User Manual 5 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 Replace t
8. verse reactions refer to the Empi Phoenix Device User s Manual e Single Patient Use Only Do not share the garment with other persons because of the risks of adverse skin reactions and disease transmission e Not a brace The specialized garment is not intended to be used as a brace lower leg support e Use during activity This garment is intended to be used in a seated position or in accordance with your clinician s orders Muscle contractions caused by the device could affect walking or balance Application on broken skin Should a skin rash or skin burn occur immediately discontinue use and contact your physician e Power connection Do not connect the garment to an AC power source or other equipment not specified as safe for the garment Doing so could result in severe shock or burns whether or not the garment is attached to the stimulator The leadwires should only be connected to the device and the garment Electrodes The garment should never be used without the three Phoenix Garment Electrodes Thermal burns may result from use without all electrodes Electrodes should be securely fastened to prevent inadvertent disconnection Electrodes will eventually wear out Check accessories regularly for signs of wear and replace as needed Skin reactions On rare occasions therapy can result in transient skin reactions such as rash inflammation irritation or burns These skin reactions may be the result of individual sensitivity th
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