Empi Phoenix User manual

Empi

CONDUCTIVE GARMENT

USER’S MANUAL

• Read carefully before using this Garment

• Visit www.djoglobal.com

™

Phoenix Garment User Manual

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 device 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).

Table of Contents

Product Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Glossary of Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Warnings and Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Garment Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Environmental Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Storage and Transport Conditions . . . . . . . . . . . . . . . . . . . . . . . . . 6

Electrode Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Ordering . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Phoenix Garment User Manual

Glossary of Symbols

This device may contain one or more of the following symbols:

Warnings and Precautions

For a full list of relevant contraindications, warnings, precautions and adverse reactions,

refer to the Empi Phoenix Device User’s Manual.

• Single Patient Use Only: Do not share the garment with other persons because of the

risks of adverse skin reactions and disease transmission.

• Not a brace: The specialized garment is not intended to be used as a brace/lower leg

support.

• 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.

• Power connection: Do not connect the garment to an AC power source or other

equipment not specied 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, inammation, irritation or burns. These skin reactions may be the result of

individual sensitivity, the condition of the skin at the onset of treatment, or a reaction to

the materials in the electrodes or garment.

• Safety: The safety and efcacy 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 ame.

• 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.

Refer to Instruction Manual/Booklet

Caution: For Prescription Only

Federal law (USA) restricts this device

to sale by or on the order of a physician

(or licensed practitioner).

Precautionary Instructions

Keep Dry

No Latex

Keep Away from Sunlight

Min and Max storage

temperatures.

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

specic use instructions.

ONLY

USA +27°

+5°C

+80.6

°F

+41.0

°F

Phoenix Garment User Manual

Garment Use

1. Lay the garment at 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 electrodes 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

If you are using the garment for your RIGHT leg,

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.

5. Sit on the edge of a rm, stable chair with your

knee slightly bent and your foot at on the oor.

If your clinician instructed you to use the device

and garment in a different setting or position,

follow your clinician’s instructions.

Fig. 1 Left

Fig. 2

Right

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.

7. Wrap the two straps underneath and around your

thigh and afx the Velcro™ 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 electrodes 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 rmly 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

the at, wide strap in the middle section of the

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

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 the 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

• Temperature Range: 10º C to 40º C (50º F to 104º F)

•Atmospheric Pressure Range: 50kPA to 106 kPa

• Relative Humidity Range: 30% to 75%

Storage and Transport Conditions

•Temperature Range: -40º C to 70º C (-40º F to 158º F)

• Atmospheric Pressure Range: 50kPA to 106 kPa

• Relative Humidity Range: 10% to 90%

Electrode Use

You can extend the use of your Phoenix Garment Electrodes by following these

suggestions:

• Cleanse, rinse and dry skin prior to use.

• Store electrodes as indicated above and on electrode packaging.

• If 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.

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 ofcially 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 specically 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))

Manufactured in Mexico for:

Empi, Inc.

205 Hwy 22 East

Clear Lake, SD 57226 USA

+1 651 415 9000

EU Authorised Representative

MDSS GmbH

Schiffgraben 41

30175 Hannover

Germany

Empi

COMPLETE

ELECTROTHERAPY

SYSTEM

USER’S MANUAL

• Read this manual carefully before operating the Phoenix™

• Visit us at www.djoglobal.com

™

Phoenix User’s Manual

Table of Contents

1. Foreword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

2. Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

2.1 Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

2.2 Use Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

3. Explanation of Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

4. Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

4.1 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

4.2 Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

4.3 Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

4.4 Dangers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10

4.5 Adverse Reactions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

5. How Does Electrotherapy Work? . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

6. Usage Guidelines. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12

6.1 Program Descriptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

6.1.1 Endurance – P1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

6.1.2 Strength – P2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

6.1.3 Modulated TENS – P3. . . . . . . . . . . . . . . . . . . . . . . . . . . . .14

6.1.4 Edema – P4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14

6.2 Choice of the Appropriate Program . . . . . . . . . . . . . . . . . . . . . . . . . 14

6.3 Planning of Stimulation Sessions . . . . . . . . . . . . . . . . . . . . . . . . . . 15

6.4 Electrode Positions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

6.4.1 Use of the Empi Phoenix Thigh Garment . . . . . . . . . . . . . . . . . . . 15

6.5 Stimulation Positions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

6.6 Adjusting Stimulation Energies . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

7. Operating Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17

7.1 Description of the Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

7.2 Kit Composition and Accessories Description . . . . . . . . . . . . . . . . . . . .18

7.3 Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

7.3.1 Insertion/replacement of the batteries . . . . . . . . . . . . . . . . . . . . . 19

7.3.2 Connection of the lead wires to the device . . . . . . . . . . . . . . . . . . 19

7.3.3 Placement and care of the electrodes . . . . . . . . . . . . . . . . . . . . . 20

7.3.4 Connection of the lead wires to the electrodes . . . . . . . . . . . . . . . . 20

7.3.5 Use of the Empi Phoenix Thigh Garment (optional). . . . . . . . . . . . . . .20

7.4 Operation of the Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

7.4.1 LCD Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

7.4.2 Operation Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

7.4.3 Operating Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

7.4.4 Pause Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

7.4.5 End of Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

7.4.6 Use of the Hand Switch (optional) . . . . . . . . . . . . . . . . . . . . . . . 22

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