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AxioBionics Wearable Therapy User Manual, Care & Instructions

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USER GUIDE,
CARE & INSTRUCTIONS
We a rab l e Th e ra py®
SU RFACE ELEC T R I C A L ST I M UL AT I O N
SYST EM
1

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Summary of Contents for AxioBionics Wearable Therapy

  • Page 1 USER GUIDE, CARE & INSTRUCTIONS We a rab l e Th e ra py® SU RFACE ELEC T R I C A L ST I M UL AT I O N SYST EM...

  • Page 2: Indications For Use

    Indications For Use: The Axiobionics Wearable Therapy Garments with Cutaneous Electrodes are Intended to be Used to Apply Electrical Stimulation Current to the Patient’s Skin via Electroconductive Media Gel. Examples of Electrical Stimulation Applications of the Garment Are: 1) Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Relief, 2) Neuromuscular Electrical Stimulation (NMES) for: •...
  • Page 3 WARNINGS and CAUTIONS in the manuals. Failure to follow instructions can cause harm to user or device. Before wearing the Wearable Therapy electrode garment it is imperative that you understand all precautions and contraindications. Refer to your stimulator manual for information pertaining to stimulator procedures and safety precautions.

  • Page 4: Adverse Reactions

    After removing the Wearable Therapy System, it is Do not use the Wearable Therapy System without normal for the areas under the pocket electrodes to the electrodes. NEVER use the garment when one or be red and indented.

  • Page 5: E L Ec Trode P Re Par At Io N

    E L EC TRODE P RE PAR AT IO N Wearable Therapy electrode garments require BioGel in each electrode pocket for electricity to transmit to the body. Only if the proper amount has been injected will the garment perform as expected and in a safe manner.
  • Page 6 AP PLYIN G E L EC T RO DE S TO T H E G AR ME NT 122P 122P 122P Once the electrode has been Orient the electrode in the same Electrical contact is made by prepared, attach it to the garment. direction as the nearest icon.
  • Page 7 PROTO CO LS Protocol 1 Ramp Up 3 Seconds On Duration 10 Seconds Off Duration 10 Seconds Rate 25 Hz Width 300 Pulse Mode EMS A (Alternate) CH1: CH2: Patient: Protocol 2 4 Channel 2 Channel Ramp Up 3 Seconds Stimulator Stimulator On Duration 10 Seconds...

  • Page 8: St Im Ul Ator S E T Up

    Once on the body, gelled, and Increase the intensity of channel connected to the stimulator, #1 to the level that produces the Wearable Therapy electrode the best result your AxioBionics garment is ready for operation. clinician may have provided you with suggested intensity levels.
  • Page 9 STOR IN G T HE E L E C T RO DE S Storing the Electrodes Step 1. After using the garment, remove it from your body and lay the garment flat with the elec- trodes facing upwards. Step 2. Remove electrodes and place the gelled, non- Velcro side of each electrode onto the gelled, non-Velcro side of its mate and place them inside an air-tight container to prevent evapora-...
  • Page 10 CL E AN I N G T H E G AR ME NT How to Clean the Garment BioGel Velcro electrode should be washed at least once Step 3. Soak garment and its integrated wires and ca- per week while in use. bling in bath until gel and soil has loosened from the garment.
  • Page 11 CL E ANI N G T H E GAR ME N T Step 5. Once the washing is complete, lay the garment Step 8. For faster drying time, place the garment di- on a dry towl.. rectly in front of a fan. Step 6.
  • Page 12 CL EA N IN G T HE E L E C T RO DE Step 3. Soak electrodes in bath until gel has loosened How to Clean the Electrode from the interior. If gel has dried, longer soaking BioGel Velcro electrodes should be washed at least once time may be required.
  • Page 13 CLE A N IN G T HE EL E C T RO D E Step 5. Rinse electrodes thoroughly by hand using cool Step 8. Remove the electrodes from the towel and lay or lukewarm water until they are free of soap flat until completely dry and gel.
  • Page 14 Figure 4 Figure 3 1. Patient should be lying down facing up. Place strap behind back. Wearable Therapy electrode 2. Place AB panel on the abdomen below the ribs and above the symphysis garments must be applied directly to pubis. (Figure 1) skin.
  • Page 15 Figure 4) 2. Wrap BioBelt around the body and fasten the left and right sides together. The BioBelt should be Wearable Therapy electrode applied with firm pressure. (Figure 2) garments must be applied directly to skin. No Clothing should intervene 3.
  • Page 16 3. Wrap BioBelt around the body and fasten the left and right sides together. The BioBelt should be applied with firm pressure. (Figure 2) Wearable Therapy electrode 4. Grab the outer elastic bands and pull forward. Fasten garments must be applied directly to these two bands to the belt for increased support.
  • Page 17 Front 1. Fasten the left and right side panels to the back panel by aligning the orange dots as noted in the figure Wearable Therapy electrode above. garments must be applied directly to 2. Align BioMiniBelt center tabs with the center of skin.
  • Page 18 (gluteal muscles) over the gluteal electrodes and centers the buttocks on the electrodes. The belt is wrapped around the torso and fastened. (Figure 2) Wearable Therapy® electrode garments must be applied directly to skin. No Clothing should intervene between electrode and skin.
  • Page 19 (Figure 2) The buttocks are centered over the gluteal electrodes and the belt is fastened. (Figure 2) Wearable Therapy® electrode garments must be applied directly to skin. No Clothing should intervene between electrode and skin.
  • Page 20 Figure 5 1. Position BioShorts under the body as shown. (Figure 1) 2. Wrap the BioShorts around each leg and fasten securely to the hook Wearable Therapy electrode opposite the strap. (Figure 2) garments must be applied directly to 3. Be sure to pointer is center on the knee as shown. (Figure 3) skin.
  • Page 21 Left 1. Apply the BioSleeve to the lower leg, just below the knee cap. (Figure 1) Wearable Therapy electrode garments must be applied directly to 2. Align the pointer so it is pointing at the center of skin. No Clothing should intervene the knee.
  • Page 22 4. Fasten each strap securely moving up the arm one strap at a time. (Figure 2) Wearable Therapy electrode 5. If there is a pointer on the sleeve near the elbow, align this with garments must be applied directly to the center of the front of the elbow crease.
  • Page 23 APP LYI N G T HE GAR ME N T Figure 4: Top of Wrist Figure 5: Shoulder Figure 6: Elbow Crease Figure 6 : Fitting of garment Front Back Side Pag e 21 of 38...
  • Page 24 (Figure 3) 4. Fasten each strap securely moving up the arm one strap at a time. (Figure 3) Wearable Therapy electrode 5. If there is a pointer on the sleeve near the garments must be applied directly to elbow, align this with the center of the front skin.
  • Page 25 APP LYI N G T HE GAR ME N T Figure 5: Top of Wrist Figure 6: Shoulder Figure 7: Elbow Crease Figure 7: Fitting of garment Back Side Side Pag e 23 of 38...
  • Page 26 Postion so that longest part of the sleeve aligns with muscles in the top of the forearm. Wearable Therapy electrode 2. Pull straps to tighten around arm. Affix straps garments must be applied directly to to the Velcro on the sleeve.
  • Page 27 2. Align pointer arrow with center of knee. 3. Pull straps around the back of the leg and afix to the velcro in the front. Wearable Therapy electrode 4. Continue to pull straps around and affix ends of straps to Velcro on the garments must be applied directly to base of the strap.
  • Page 28 2. Close the front fasteners. (Figure 2) 3. Tighten the left and right hip straps (if necessary) . (Figure 4) Wearable Therapy electrode garments must be applied directly to 4. Position the vest on the body where it should be located. Tighten the over skin.
  • Page 29 (Figure 1) 2. Close the front zipper. (Figure 2) 3. Tighten belt around waste. (Figure 3) Wearable Therapy electrode garments must be applied directly to 4. Tighten the left and right hip straps. (Figure 4) skin.
  • Page 30 AP PLYI N G T HE GA R ME NT Figure 5 Figure 6 Figure 7 Pag e 28 of 38...
  • Page 31 If the vest has side straps leave them unfastened or belt . (Figures 1 and 2) 2. Close the front zipper. (Figure 3) Wearable Therapy electrode 3. Fasten privacy panel to front of garment. (Figure 4) garments must be applied directly to skin.
  • Page 32 1. Place garment at behind your neck with the pocket facing down. 2. Pull straps until garment is snug. Wearable Therapy electrode 3. Affix straps to Velcro on BioVest. garments must be applied directly to skin. No Clothing should intervene...
  • Page 33 You should never increase the amount of at the metacarpal-phalangeal joint (MCP) is undesirable, time you are using the Wearable Therapy System if you but may be unavoidable if contracture of the flexor have excessive muscle soreness or experience pain.
  • Page 34 ACCLI MATI N G TO WE AR AB L E T H ER APY Slow Acclimation Schedule Morning Session Afternoon Session Pag e 32 of 38...
  • Page 35 ACCL I MATI N G TO WE A R AB LE T H E R A PY Fast Acclimation Schedule Morning Session Afternoon Session Pag e 33 of 38...
  • Page 36 ACCLIMAT IO N MONITORING FO RM...
  • Page 37 PAR AME T ER SE T TI NGS FOR M...
  • Page 39 This page intentionally left blank...
  • Page 40 6111 Ja ckson Rd , Suite 200 Ann Arbor, MI 48103 800.552.3539 CAUTION: Federal law restricts the device to sale by or on the order of a physician or a practitioner trained in its use. P/N 0000807 V2.0...