360413 INSTRUCTIONS FOR USE PHOENIX USER`S MANUAL A

360413 INSTRUCTIONS FOR USE PHOENIX USER`S MANUAL A
DOCUMENT NO.
360413
SH 1
OF
42
TYPE OF DOCUMENT
INSTRUCTIONS FOR USE
PRODUCT NAME
PHOENIX USER’S MANUAL
REVISION
REV.
ECO
A B EC13‐249 EC15‐103 DESCRIPTION
RELEASED Remove all information about the carrying pouch and update the ETL symbol. Remove all information about the DVD DATE
APPR
6‐4‐13 VLC 16 JUN 15
DAM
DOCUMENT NO.
REV.
360413
B
TYPE OF DOCUMENT
IFU, PHOENIX USER’S MANUAL
SPEC:
FINISHED SIZE:
8.5 X 5.5
PORTRAIT
2 SIDED
COLOR:
4-COLOR
PAPER:
Cover: 80# Gloss Cover Coated
Text: 60# Opaque Text
Saddle stitch
SH
2
OF
42
Empi
™
COMPLETE
ELECTROTHERAPY
SYSTEM
USER’S MANUAL
• Read this manual carefully before operating the Phoenix™
• Visit us at www.djoglobal.com
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
2
Phoenix User’s Manual
7.5 Meaning of Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
7.5.1 Intensity Lock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
7.5.2 Sequence Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
7.5.3 Work/Rest Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
7.5.4 Timer Indication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
7.5.5 Low Battery Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
7.5.6 Open Circuit Icon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
8. Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
9. Device Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
26
9.1 Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
9.2 Cleaning and Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
9.3 Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
9.4 Operating Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
9.5 Transportation and Storage Conditions . . . . . . . . . . . . . . . . . . . . 27
9.6 Expected Life and Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . 27
10. Ordering Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
11. Clinician Only Section . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
11.1 Compliance Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
11.2 Program Lock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
11.3 Ordering Information for Clinicians . . . . . . . . . . . . . . . . . . . . . . 29
12. Limited Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
29
13. Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
32
14. Guidance and Manufacturer’s Declaration – Electromagnetic Emissions . . . . .
34
15. Additional Information on Electrode Placement for Knee Treatment . . . . . . 38
16. Q
uick Start Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Phoenix User’s Manual
3
1. Foreword
The Empi Phoenix is a multifunctional electrotherapy device that provides two channels of
neuromuscular electrical stimulation (NMES), transcutaneous electrical stimulation (TENS),
or pulsed DC (Edema treatment). This wide-ranging capability allows the patient to receive
electrotherapy throughout the recovery cycle using a single device. Its simplified programming
makes the device convenient for home use: after placing the electrodes and selecting the
program as prescribed by a healthcare professional, the patient only needs to increase the
intensity to begin therapy.
The Phoenix device’s NMES Endurance and Strength programs utilize an electrical stimulus
that, when properly applied, activates specific muscles or muscle groups to help treat disuse
atrophy and re-educate muscles. The pre-set programs are designed to provide therapeutic
benefit while minimizing complexity for the patient and clinician. 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.
The Phoenix device also includes a traditional TENS program for pain management and a
pulsed DC Edema program to increase local blood circulation and reduce edema (swelling).
Read this User Manual carefully before using the Phoenix device. Pay particular
attention to the Safety Information in Section 4 and additional warnings throughout
the manual.
Caution: Federal law restricts this device to sale by or on the order of a practitioner
licensed by the law of the State in which he/she practices to use or order the use of
the device.
4
Phoenix User’s Manual
2. Intended Use
2.1 Indications for Use
As an NMES device, indications are for the following conditions:
• Retarding or preventing disuse atrophy
• Maintaining or increasing range of motion
• Re-educating muscles
• Relaxation of muscle spasms
• Increasing local blood circulation
As a TENS device, indications are for the following conditions:
• Symptomatic relief and management of chronic, intractable pain
• Adjunctive treatment for post-surgical and post-trauma acute pain
• Relief of pain associated with arthritis
As a pulsed current device, indications are for the following conditions:
• Reduction of edema (under negative electrode)
• Reduction of muscle spasm
• Influencing local blood circulation (under negative electrode)
• Retardation or prevention of disuse atrophy
• Facilitation of voluntary motor function
• 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.
Phoenix User’s Manual
5
3. Explanation of Symbols
The following symbols are used either in this user manual, on the device packaging, or on the
device label. They may also appear on an accessory.
Symbol
Explanation
Reference number; part number
Lot number
Follow instruction for use
Type BF applied parts
Keep the device dry
Keep the device away from sunlight
Protected against solid foreign objects of 12.5 mm (0.5 in) diameter and greater
Protected against vertically falling water drops when enclosure tilted up to 15°
Minimum and maximum temperature indications to respect
Prescription only (USA)
ETL Classified C US, 9900900, Electronic Testing Lab, indicates product meets
US and Canadian product safety standards. This device Conforms to AAMI Std.
ES60601-1. Certified to CAN/CSA Std. C22.2#60601-1.
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)
6
Phoenix User’s Manual
4. Safety Information
This section includes Contraindications, Warnings, Precautions, Dangers, and Adverse
Reactions.
4.1 Contraindications
Implanted electronic devices. Do not use the Empi Phoenix device on patients who have a
cardiac pacemaker, implanted defibrillator, or other implanted electronic device, because this
may cause electric shock, burns, electrical interference, or death.
TENS for undiagnosed pain. Do not use the Empi Phoenix device as a TENS device (P3) on
patients whose pain syndromes are undiagnosed.
4.2 Warnings
Consult with physician. Consult with the patient’s physician before using the Empi Phoenix
device, because the device may cause lethal rhythm disturbances to the heart in susceptible
individuals.
Skin condition. Apply stimulation only to normal, intact, clean, healthy skin.
Long term effects. The long-term effects of chronic electrical stimulation are unknown.
Stimulation location
Stimulation over neck or mouth. Do not apply stimulation over the patient’s neck
(especially the carotid sinus) or the patient’s mouth, because this could cause severe muscle
spasms resulting in closure of the airway, difficulty in breathing, or adverse effects on heart
rhythm or blood pressure.
Stimulation across chest. Do not apply stimulation across the patient’s chest, because the
introduction of electrical current into the chest may cause rhythm disturbances to the patient’s
heart, which could be lethal.
Across the head. Since the effects of stimulation of the brain are unknown, stimulation
should not be applied across the head, and electrodes should not be placed on opposite
sides of the head.
Stimulation over compromised skin. Do not apply stimulation over open wounds or
rashes, or over swollen, red, infected, or inflamed areas or skin eruptions (e.g., phlebitis,
thrombophlebitis, varicose veins).
Stimulation near cancerous lesions. Do not apply stimulation over, or in proximity to,
cancerous lesions.
Stimulation over metallic implants. Do not apply stimulation directly over implanted
metallic devices, because this may cause shock or burns.
Stimulation over eyes. Do not apply stimulation directly on the eyes.
Environment
Electronic monitoring equipment. Do not apply stimulation in the presence of electronic
monitoring equipment (e.g., cardiac monitors, ECG alarms), which may not operate properly
when the electrical stimulation device is in use.
Bath or shower. Do not apply stimulation when the patient is in the bath or shower. Do not
apply stimulation in humid atmosphere exceeding 75% of relative humidity.
Phoenix User’s Manual
7
Sleeping. Do not apply stimulation while the patient is sleeping.
Driving or operating machinery. Do not apply stimulation while the patient is driving,
operating machinery, or during any activity in which electrical stimulation or involuntary muscle
contraction can put the patient at risk of injury.
Electrosurgical equipment or defibrillators. Disconnect the Empi Phoenix stimulation
electrodes before using electrosurgical equipment or defibrillators. Otherwise skin burns may
be caused below the electrodes and the Empi Phoenix device might be destroyed.
Magnetic Resonance Imaging. Do not wear electrode or the Empi Phoenix device during
Magnetic Resonance Imaging (MRI) scans as this may result in metal overheating and causing
skin burns in the area of the electrode.
Flammable or explosive environment. Do not use the Empi Phoenix device in areas
where there is a risk of fire or explosion, such as oxygen-rich environments, in the vicinity of
flammable anaesthetics, etc.
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.
Miscellaneous
Garment and electrodes for single patient. Do not share electrodes or garments with
other persons. All users should have individual set of electrodes to prevent undesirable skin
reactions or disease transmission.
Accessories. Use this device only with the leads, electrodes, and accessories recommended
by Empi. Use of other accessories may adversely affect the performance of the device or may
result in stronger electromagnetic emissions or reduce the electromagnetic immunity of the
Empi Phoenix device.
No Modification. No modification of the equipment is allowed.
4.3 Precautions
Supervision. Use this device only under the continued supervision of a licensed practitioner.
Electrode placement and stimulation settings should be based on the guidance of the
prescribing practitioner.
Pregnancy. The safety of electrical stimulation during pregnancy has not been established.
Skin irritation. Some patients may experience skin irritation or hypersensitivity due to the
electrical stimulation or electrical conductive medium (gel). The irritation may be reduced by
using an alternate conductive medium or alternate electrode placement. Some patients may
experience redness under the electrodes after a session. This redness usually disappears
within a few hours. Advise the patient to consult the clinician if the skin redness does not
disappear after a few hours. Do not start another stimulation session in the same area if the
redness is still visible. Don’t scratch the redness area.
Heart disease. Patients with suspected or diagnosed heart disease should follow
precautions recommended by their physicians.
Epilepsy. Patients with suspected or diagnosed epilepsy should follow precautions
recommended by their physicians.
Internal bleeding. Use caution when the patient has a tendency to bleed internally, such as
following an injury or fracture.
After surgery. Use caution following recent surgical procedures when stimulation may disrupt
the patient’s healing process.
Over uterus. Use caution if stimulation is applied over the menstruating or pregnant uterus.
8
Phoenix User’s Manual
Lack of sensation. Use caution if stimulation is applied over areas of skin that lack normal
sensation. Don’t apply stimulation on patient unable to express themselves.
Hot casing or batteries. Under extreme use conditions, some parts of the casing might
reach up to 109 °F (43 °C). Use caution when manipulating the batteries right after device use
or when holding the device. There is no particular health risk associated with this temperature
besides your comfort.
Children. Keep this device out of the reach of children.
Electrode size. Do not use electrodes with an active area less than 16 cm2, as there will be a
risk of suffering a burn injury. Caution should always be exercised with current densities more
than 2mA/cm2.
Strangulation. Do not wrap leadwires around your neck, and keep them out of the reach of
children. Strangulation may result from entanglement in the leadwires.
Tripping. Care should be used to avoid tripping on lead wires.
Damaged device or accessories. Never use the Empi Phoenix device or any of its
accessories if it is damaged (case, cables, etc.) or if the battery compartment is open as there
is a risk of electric shock. Carefully inspect the lead wires and connectors prior to each use.
Inspect electrodes. Inspect electrodes before each use. Replace electrodes when they
begin to deteriorate or lose adhesion. Poor contact between the electrodes and the patient’s
skin increases the risk of skin irritation or burns. Electrodes will last longer if used and stored
according to instructions on electrode packaging. Attach the electrodes in such a way that
their entire surface is in contact with the skin.
Foreign bodies. Do not allow any foreign bodies (soil, water, metal, etc.) to penetrate the
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.
Batteries. Do not carry batteries in a pocket, purse, or any other place where the terminals
could become short-circuited (e.g. by way of paper clip). Intense heat could be generated and
injury may result.
Heat and cold products. The use of heat or cold producing devices (e.g. electric heating
blankets, heating pads or ice packs) may impair performance of the electrode or alter the
patient’s circulation/sensitivity and increase the risk of injury to the patient.
Pulled muscles. Do not apply electrodes over pulled muscles. Using the stimulator on
a previously extended muscle might further pull such muscle. The higher the stimulation
intensity, the higher the risk to further overextend such muscle.
DC Component. The Empi Phoenix waveforms may contain a DC component (only for
Edema program P4). Always use Empi electrodes with a minimum active area of 16 cm2
(including Empi square (2” x 2”) StimCare electrodes). Use of an electrode with an area less
than 16 cm2 can cause burns when the unit is used at higher intensities. Consult your clinician
prior to using any electrode less than 16 cm2.
This DC component for the Edema program (P4) is equivalent to 266 µA DC for all intensities
above 4 mA.
Additional Precautions for TENS (P3)
• TENS is not effective for pain of central origin, including headache.
• TENS is not a substitute for pain medications and other pain management therapies.
• TENS devices have no curative value.
• TENS is a symptomatic treatment and, as such, suppresses the sensation of pain that
would otherwise serve as a protective mechanism.
• Effectiveness of TENS is highly dependent upon patient selection by a practitioner
qualified in the management of pain patients.
Phoenix User’s Manual
9
4.4 Dangers
Electrodes. Any Empi Electrode with a minimum active area of 16 cm2 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 cm2 can cause burns when the unit is used at
higher intensities. Consult your clinician prior to using any electrode less than 16 cm2.
Dangerous voltage. Stimulus delivered by the waveforms of the Phoenix device,
in certain configurations, will deliver a charge of up to 20 microcoulombs (µC) or
greater per pulse and may be sufficient to cause electrocution. Electrical current of
this magnitude must not flow through the thorax because it may cause a cardiac
arrhythmia.
4.5 Adverse Reactions
• Patients may experience skin irritation and burns beneath the stimulation electrodes
applied to the skin.
• Patients may experience headache and other painful sensations during or following
the application of electrical stimulation near the eyes and to the head and face.
• Patients should stop using the device and should consult with their physicians if they
experience adverse reactions from the device.
10
Phoenix User’s Manual
5. How Does Electrotherapy Work?
The principle of electrotherapy is to stimulate nerve fibers by means of electrical impulses
transmitted by electrodes. The NMES electrical pulses generated by the Empi Phoenix
stimulators are high-quality pulses that have been clinically tested and offer safety, comfort,
and efficiency. These electrical pulses can:
• Stimulate motor points of target muscles, causing a muscle contraction. This can help
re-educate and strengthen your muscles following an injury or surgery. This is called
neuromuscular electrical stimulation (NMES). The Empi Phoenix programs P1 and P2
are NMES programs.
• Manage pain. The electrical pulses block the pain signal sent from the affected area
on your nerve pathways. This is called the “Gate Theory” of pain control, and this form
of electrotherapy is called transcutaneous electrical nerve stimulations (TENS). The
Empi Phoenix program P3 is a TENS program.
• Increase local blood circulation, helping to reduce swelling or edema. The electrical
current can affect the movement of fluid through tissue, and increasing blood flow can
help increase healing. This therapy can be achieved using a pulsed direct current. The
Empi Phoenix program P4 is a pulsed, direct-current program.
During voluntary activity, the brain sends a command to the nerve fibers in the form of an
electrical signal to give the order to move. This signal is then transmitted to the muscular
fibers, which contract. The principle of electrotherapy emulates the process observed during
a voluntary contraction. 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.
In fact, different types of muscular fibers may be distinguished according to their respective
contraction speed: slow, intermediate, and fast fibers. Fast fibers would predominate in a
sprinter, while a marathon runner would likely have more slow fibers. With a good knowledge
of human physiology and well‐designed stimulation programs, muscular work can be directed
very precisely towards the desired goal (muscular re-education, relaxation of muscle spasm,
pain management, increased blood flow, maintaining, or increasing range‐of‐motion, etc.)
Electrical pulse
Excitation
Transmission
of the excitation
Motor
nerve
Stimulated
muscle
Elementary Mechanical Response - Twitch
Phoenix User’s Manual
11
6. Usage Guidelines
6.1 Program Descriptions
The choice of a program is determined by the injured body parts or joints. The appropriate
stimulation programs (e.g., Endurance, Strength, TENS, or Edema) and frequency of the
program(s) are determined by the medical professional. Consult your medical professional to
be sure to understand the 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. The purpose is to increase the time for the muscle to maintain a
medium contraction or the average power level for extended periods of time. This program
is recommended for use before and after the surgery as prescribed by your medical
professionals.
P1 begins with a two-minute Warm-Up phase, which will count down on the screen. The
Warm-Up phase will cause your muscles to twitch but not contract. Set the device intensity
to a comfortable level during Warm-Up. Once the Work phase begins, the intensity will
automatically decrease by half. You can then adjust the intensity to provide a comfortable
but strong muscle contraction. The program finishes with a Cool-Down phase similar to the
Warm-Up phase.
ENDURANCE (P1)
Waveform
WARM UP
Treatment time
Cycling type
Pulse duration
Frequency - warm up
WORK PHASE
Treatment time
Cycling type
Symmetrical square biphasic asynchronous
SETTING
2 min
Continuous
300μs
6 Hz
SETTING
15 min
Intermittent
Pulse duration
300μs
Frequency - work
35 Hz
Frequency - rest
4 Hz
Work time
6 sec
Rest time
7 sec
Ramp up time work
1.5 sec
Ramp down time work
0.75 sec
Ramp up time rest
0.5 sec
Ramp down time rest
0.5 sec
12
Phoenix User’s Manual
COOL DOWN
Treatment time
Cycling type
SETTING
3 min
Continuous
Pulse duration
300μs
Frequency – cool down
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. This program targets the muscle fibers
that are typically afflicted with immediate atrophy after injury or/and surgery.
P2 begins with a two-minute Warm-Up phase, which will count down on the screen.
The Warm-Up phase will cause your muscles to twitch but not contract. Set the device
intensity to a comfortable level during Warm-Up. Once the Work phase begins, the intensity
will automatically decrease by half. You can then adjust the intensity to provide a comfortable
but strong muscle contraction. The program finishes with a Cool-Down phase similar to the
Warm-Up phase.
STRENGTH (P2)
Waveform
WARM UP
Treatment time
Cycling type
Pulse duration
Frequency - warm up
WORK PHASE
Treatment time
Cycling type
Symmetrical square biphasic asynchronous
SETTING
2 min
Continuous
300μs
6 Hz
SETTING
15 min
Intermittent
Pulse duration
300μs
Frequency - work
75 Hz
Frequency - rest
4 Hz
Work time
4 sec
Rest time
10 sec
Ramp up time work
1.5 sec
Ramp down time work
0.75 sec
Ramp up time rest
0.5 sec
Ramp down time rest
COOL DOWN
Treatment time
Cycling type
Pulse duration
Frequency – cool down
Phoenix User’s Manual
0.5 sec
SETTING
3 min
Continuous
300μs
3 Hz
13
6.1.3 Modulated TENS – P3
This treatment is a modulated TENS program for the treatment of post-surgical or chronic
pain. Use this program with direct lead wires and electrodes (included in the device box),
not with the garment. Place the electrodes around the site of the pain.
TENS
PARAMETER
Waveform
SETTING
Symmetrical square biphasic
asynchronous, frequency modulated
Treatment time
Unlimited*
Cycling type
Continuous
Pulse duration
80μs
Frequency 1
120 Hz
Frequency 2
90 Hz
Modulation time
4 sec
* “Unlimited” means that the timer does not automatically stop the
treatment after a set time.
6.1.4 Edema – P4
This treatment option is a sequenced, net positive DC 2-channel program for edema reduction
and increased circulation. For acute Edema (less than 48 hours post-injury or post-op), place
the positive electrodes over the treatment site and attach the negative leadwire pins to the
dispersive pad. For chronic Edema (no immediate prior injury/surgery or more than 48 hours
post-injury or post-op), place the negative electrodes over the treatment site and attach the
positive leadwire pins to the dispersive pad.
EDEMA
PARAMETER
Waveform
Treatment time
SETTING
Net positive pulsed DC
30 min
Cycling type
Continuous
Pulse duration
60-120 Hz
Frequency
222Hz
6.2 Choice of the Appropriate Program
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.
14
Phoenix User’s Manual
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.
Please also refer to the pictures and pictograms shown at the bottom of this section. For best
results, wash and clean the skin and dry it before attaching the electrodes.
Each stimulation cable has two pins:
A positive pin (+) = red connection
A negative pin (-) = black connection
An electrode should be connected to each pin. Always follow your clinician’s instructions
about electrode connection and application. Attach the electrodes in such a way that their
entire surface is in contact with the skin.
Precaution: Do not disconnect any stimulation cables during a session while the
stimulator is switched on. Switch the stimulator off first. Always turn off the stimulator
before moving or removing any electrodes during a session.
Precaution: Do not use electrodes with an active area less than 16 cm2, as there will
be a risk of suffering a burn injury. Caution should always be exercised with current
densities more than 2mA/cm2.
Precaution: Do not apply stimulation in the vicinity of metal. Remove jewelry, body
piercings, buckles or any other removable metallic product or device in the area of
stimulation. Never use the electrodes contra-laterally; i.e., do not use two pins
connected to the same channel on opposite segments of the body.
Depending on the characteristics of the current, efficacy can be optimized in certain programs.
When working with a muscle stimulation program (program involving muscle contractions, P1
or P2), it is important to place the negative electrode (connected to the black connector) on
the motor point of the muscle.
To ensure the efficacy of the program, it is crucial to choose the right size electrodes (large
or small) and correctly position these on the muscle group you want to stimulate. Therefore,
always use the size of electrodes your clinician instructs you to use. When using the garment,
always use the provided electrodes and electrode placements unless you have explicit
instructions otherwise from your clinician. Use the Empi Phoenix Thigh Garment only with P1
and P2, not with P3 or P4.
6.4.1 Use of the Phoenix Thigh Garment
The Empi Phoenix Thigh Garment can be used as an accessory to help you position and hold
the electrodes in place for the Endurance (P1) and Strength (P2) programs. Please refer to the
Empi Phoenix Garment User Manual for proper use of the Empi Phoenix Thigh Garment with
the Empi Phoenix device.
Phoenix User’s Manual
15
6.5 Stimulation Positions
Your body position during therapy will vary depending on the position of the electrodes, the
muscle group you wish to stimulate, and the program you are using. Follow your clinician’s
instructions for body positioning. One commonly recommended position for Endurance
and Strength (P1 and P2) programs for knee treatments is to be seated with your foot flat
on the floor and your knee at a 90 degree angle to allow for isometric contractions. For P1
(Endurance) and P2 (Strength) programs, you should normally stimulate isometrically; this
means that the extremities of the limb in which a muscle is being stimulated must be firmly
fixed to prevent the movement that results from the muscle contraction. Consult your clinician
for use of the device together with movements. For TENS and Edema programs (P3 and P4)
position yourself as comfortably as possible.
Precaution: Never carry out an initial stimulation session on a person who is
standing. The first five minutes of stimulation must always be performed on a person
who is sitting or lying down. In rare instances, people of a nervous disposition may
experience a vasovagal reaction. This reaction is connected with fear of the muscle stimulation
as well as surprise at seeing one of their muscles contract without having intentionally
contracted it themselves. A vasovagal reaction causes heart to slow down and blood pressure
to drop, which can make you feel weak and faint. If this does occur, stop the stimulation and
lie down with the legs raised until the feeling of weakness disappears (5 to 10 minutes).
6.6 Adjusting Stimulation Energies
When using the Endurance and Strength programs, the benefits of therapy are improved as
the electrical intensity increases. 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.
16
Phoenix User’s Manual
7. Operating Instructions
You are strongly advised to carefully read the Safety Information in Section 4 at the beginning
of this manual prior to using your stimulator.
Precaution: Sudden temperature changes can cause condensation to build up
inside the stimulator. To prevent this, allow it to reach room temperature before use.
7.1 Description of the Device
G
H
J
A
B
C
E
F
D
K
A. User Interface LCD
B. ON/OFF (Pause) button
C. Program Selection (Increase) button
D. Program Selection (Decrease) button
E. Channel 1 Intensity Increase/Decrease button
F. Channel 2 Intensity Increase/Decrease button
G. Channel 1 output connector
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
17
7.2 Kit Composition and Accessories
802425
360413
193075
200045
802427
200047
199696
193057-100
235684
199327-001
Accessory
199695
Part Number
Quantity
Description
STANDARD INCLUSIONS – PHOENIX DEVICE
Unit
199696
1
One Phoenix device
Lead wires
193057-100
(40” long)
2
Package of one leadwire
assembly with red and black pins
Standard electrodes
199327-001
2
Batteries
200045
1
Battery charger
200047
1
Battery charger
Instructions for Use
360413
1
Phoenix Instruction for use
Quick Start Guide
802425
1
Quick start guide for the patient
DVD
802427
1
DVD
Package of four carbon cloth
2"x 2" StimCare electrodes*
Package of four rechargeable AA
batteries
OPTIONAL PHOENIX THIGH GARMENT
Phoenix thigh garment
235684
1
Garment
Garment connector
193075
1
Attaches device to garment
Garment electrodes
199695
2
Packets of one 6"x 3.5" and
two 2.75" x 4" electrodes
OPTIONAL INCLUSIONS AVAILABLE UPON REQUEST
Leadwires
193057-150
(60” long)
2
Package of one leadwire
assembly with red and black pins
Dispersive pad
199501-001
1
Large 5"x 8" pad for Edema use
Bifurcated lead
700211-001
1
Split lead for Edema use
235693
1
Switch for manual stim activation
Hand switch
*Your clinician may request different electrodes.
18
Phoenix User’s Manual
7.3 Preparation
7.3.1 Insertion/replacement of the batteries
1. Remove the belt clip
by disengaging one of
the arms on the side
of the device.
2. Remove the battery
door by sliding it
downward along
the device.
4. Close the battery
door by sliding
it upward until it
clicks into place as
shown. Make sure
the battery door is
fully engaged before
switching on the
device.
5. You may or may not use the belt clip,
as you prefer.
6. Dispose of the old batteries in accordance
with local and national regulations.
3. Place the batteries
as indicated on the
bottom of the battery
compartment.
Note the polarity
and the battery type.
Use only IEC LR06
AA 1.5 V Alkaline or
rechargeable AA NiMH
1.2 V batteries.
Remove the batteries from the Empi Phoenix
device if it is not used for a prolonged period
of time (e.g. more than 3 months).
7.3.2 Connection of the lead wires to the device
Always inspect the lead wires connection before using them. If any connection is damaged,
do not use the lead wire and replace it.
1. Connect Channel 1 and
Channel 2 lead wires
into their respective
socket as shown.
2. Make sure the lead
wire is fully engaged by
pressing the leadwire
connector head firmly
into the socket.
Correct
3. You may not need to insert Channel 2
lead wire, depending on the program and
electrode configuration you are using.
Consult your clinician for instruction on how
to use the appropriate program and proper
placement of the electrode (see also Section
6.4 of this manual).
4. To disconnect the
lead wire, pull the
lead wire connector
head away from the
connector. Never
pull on the lead wire
directly to remove it
from the device, as
this may damage the
lead wire.
Incorrect
Phoenix User’s Manual
19
7.3.3 Placement and care of the electrodes
NOTE: This section applies to electrodes used with conventional leadwires. If you are using
the Phoenix Thigh Garment, please follow the Garment and Garment Electrode instructions.
1. Peel off the electrodes from the plastic film and apply them on the appropriate body area.
Follow your Clinician’s recommendation and Section 6.4 for proper electrode placement.
Always ensure the electrodes are fully in contact with the skin. If the adhesion of the
electrodes is not good, use new electrodes.
2. At the end of the treatment, first disconnect the lead wires from the electrodes. Next, peel
off the electrodes from the skin and place them back on the plastic film. Put them back
into the plastic bag and reseal it.
3. Electrodes will eventually wear out. Check accessories regularly for signs of wear and
replace as needed. Stop using electrodes if their bonding power becomes poor. Contact
Empi to order additional electrodes.
To maximize service life for electrodes:
• Clean the skin application sites with mild soap water before attaching the electrodes.
After cleaning, thoroughly rinse with water and dry the skin carefully.
• Dry electrodes with poor adhesion can be reconditioned. See electrode packaging for
complete instructions.
• If you encounter contact with the skin or repeated open lead detection, replace the
electrodes.
• Remove electrodes by pulling on their edges. Do not pull on the lead wire.
• After use, reattach the electrodes to their protective plastic film. Store the electrodes
in their bags.
• Store the electrodes in a cool place.
• We recommend clipping excess hair from sites where electrodes will be applied. Trim
the hair with scissors; do not shave.
• Do not leave the electrodes attached to your skin for a prolonged period of time.
Remove the electrodes after each use. To avoid skin irritations, apply the electrodes
to different areas and clean the skin thoroughly after treatment. If you observe skin
irritations, consult your Clinician and discontinue therapy until the irritation subsides.
7.3.4 Connection of the lead wires to the electrodes
Connect the pin end of the lead wire to the chosen electrode.
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.
20
Phoenix User’s Manual
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.
Sequence
Indicator
Low Battery Symbol
Work/Rest Symbol
Open Circuit Icon
Intensity Bar Graph
Program Locked
Program/Sequence Timer
Intensity
Locked Symbol
Intensity Display
7.4.2 Operation information
• You can interrupt therapy at any time with the ON/OFF
switch.
• If the stimulator is not used, it switches off automatically after approximately 5
minutes.
• When the therapy timer is activated, the device switches off automatically at the end
of the programmed interval. The remaining therapy time is always indicated on the
display.
• The program can only be changed when the intensity in both channels is 0.
7.4.3 Operating instructions
1. Turn on the device by pressing the ON/OFF
The software version will be displayed briefly.
button.
2. The LCD will then automatically switch to the Program Selection
Screen.
3. Use the Program Selection Increase
and Decrease
buttons to select the program prescribed by your healthcare
provider. Change of program is possible only when both
channel intensities are 0. The available programs are P1
(Endurance), P2 (Strength), P3 (TENS) and P4 (Edema). The
list of programs is also mentioned on the battery door label.
The device might be locked into a pre-defined program selected by your Clinician. In this case,
you cannot change the program selection and the Program Selection buttons are inactive. A
corresponding text will appear below the program number.
Phoenix User’s Manual
21
4. The sequence indicator will indicate the number of sequences for each program. The
program timer indicates the total duration of the program. Once you have selected the
desired program, simply increase the intensities of the channels you want using the
Increase Intensity buttons. For intensity strength information, refer to 6.6.
5. The intensity of each channel will be displayed both numerically
and with a bar graph. Note that intensities of Endurance (P1)
and Strength (P2) programs are expressed in Energy levels (max
520) while intensities of TENS (P3) and Edema (P4) programs are
expressed in mA (max 100 mA).
7.4.4 Pause function
During a treatment, you can pause the treatment at any time by pressing the ON/OFF
button once. In this case, both intensities will drop to 0, the timer will stop, and the timer
indicator will blink.
To resume the treatment, increase the intensities to the desired level. This will automatically
resume the timer.
When you are in the Pause mode, you can also switch off the unit by pressing the ON/OFF
button a second time.
7.4.5 End of treatment
For all treatments except P3 (TENS), the timer will automatically finish the treatment. When the
treatment is finished, intensities are automatically reduced to 0 and the timer indicator will flash
with 00:00.
For the TENS (P3) program, the timer is unlimited, meaning that it does not automatically
shut off after a set time. Stop the treatment after the time recommended by your healthcare
provider by pressing the ON/OFF
button.
• Turn off the device by pressing the ON/OFF
button.
Disconnect the electrodes and the lead wires as indicated in section 7.3. Electrodes no longer
fit for use can be disposed of with the normal domestic waste.
7.4.6 Use of the hand switch (optional)
The hand switch connects to the unit on the dedicated port:
The hand switch can be used to manually change the cycles of contractions/active‐rest or turn
the stimulation On and OFF.
• 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.
22
Phoenix User’s Manual
7.5 Meaning of Indicators
7.5.1 Intensity lock
If you do not adjust the intensities for 10 seconds, the intensities are automatically locked to
avoid accidental intensity modification. When the intensity lock is on, the lock symbol appears
next to the intensity displays. To unlock the intensities, press either of the Intensity Decrease
buttons. You can then re-adjust the intensity.
7.5.2 Sequence indicator
The sequence indicator is the set of three chevron symbols on the upper middle of the screen.
These symbols indicate when the program is in warm up (first chevron), treatment (second
chevron), and cool down (third chevron) modes. Each chevron is filled as that portion of
therapy occurs. For TENS (P3) and Edema (P4) treatments, there is only one sequence.
7.5.3 Work/rest indicator
The work/rest indicator is the curved line on the upper right of the screen. When the treatment
is active, this indicator will show whether the therapy is in “work mode” (contraction) or “rest
mode” (low frequency stimulation). During the “work mode”, the upper line of the symbol will
blink. During the “rest mode”, the lower part of the symbol will blink. TENS (P3) and Edema
(P4) treatments do not have a rest mode.
7.5.4 Timer indication
The timer indicates the remaining time of the active sequence. For the TENS program (P3), the
timer indicator displays —:­— as the program duration is unlimited, and does not automatically
shut off after a set time. (To end a TENS program, press the ON/OFF
button twice.)
7.5.5 Low battery indicator
When the battery voltage drops below a predefined limit, the battery
symbol appears.
If you are in the middle of a treatment, you may complete your
treatment and change the batteries before starting a new treatment.
Don’t start a new treatment without changing the batteries if the low
battery symbol is present. Please refer to section 7.3.1 for proper battery replacement.
7.5.6 Open circuit icon
The Open Circuit icon appears when the resistance between the
device and the skin is too high. The symbol appears next to the
channel bar graph where the open circuit has been detected.
The Open Circuit icon might appear due to a poor electrode
attachment or an interrupted electric circuit. 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
23
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.
Problem
Possible
cause
Batteries
A. Make sure the batteries are properly installed. (Check polarity
markings).
B. Make sure the battery contacts are clean.
Device not
answering
If the device is ON, but does not respond to pressing the key pad
buttons:
A. Detach all patient lead wires from the device;
B. Remove batteries from the device;
C. Wait 10 seconds;
D. Re-insert batteries and resume treatment.
Low batteries
If the Low Battery Indicator is visible, replace both batteries.
Bad
connection
If the device is on, the intensity bar graphs and controls are on,
and you feel no stimulation, check and verify the connection of lead
wires and electrodes.
Lead wire
or electrode
defective
If the device appears to be functioning , and there is no stimulation,
replace the lead wires and/or electrodes.
Battery
A. Try fresh batteries.
B. Ensure batteries are inserted correctly. See instructions for proper
placement.
Battery
contact failure
A. Check contacts are in place.
B. Check contacts are not broken.
C. Check contacts are not pushed in. They should make contact
when battery is inserted.
Electrodes
dried out
Replace electrodes.
Electrode
placement
Make the electrodes at least 2” apart.
Poor electrode
contact
Reapply electrodes, secure firmly. Electrodes must be a minimum
of 2” apart.
The stimulator
is not working
Display does
not come on
Weak
stimulation with
fresh batteries
Stimulation
stops with fresh
batteries
Stimulation
weakens
within minutes
of starting
treatment with
fresh batteries
24
Solution
Damaged
or worn
electrodes or
lead wires
This is a
normal body
adaptive
process
Replace.
Increase the amplitude (intensity).
Phoenix User’s Manual
Problem
Stimulation is
uncomfortable
Stimulation is
ineffective
Stimulation
only felt on one
electrode
Possible
cause
Solution
Amplitude
(intensity) is
too high
Decrease amplitude (intensity).
Electrodes
are too close
together
Reposition the electrodes. Electrodes must be a minimum of 2
inches apart.
Damaged
or worn
electrodes or
leadwires
Replace.
Ensure proper
program is
being used
A. Refer to section 6.1 for a description of the Programs
B. Contact clinician if discomfort persists.
Improper
electrode
placement
Reposition electrodes. Electrodes must be a minimum of 2 inches
apart.
Unknown
Contact clinician.
Improper
electrode
placement
A. Reposition electrodes. Electrodes must be a minimum of 2 inches
apart.
B. Replace electrodes.
Electrodes:
A. Worn or
damaged
Stimulation on
one channel
(side) only
B. Improper
placement
Leadwires
worn or
damaged
Replace.
Component
failure
Try each leadwire independently in each channel. If there is no
output on either channel the leadwire is defective and should be
replaced. If there is output on one channel only, a component
may have failed. Call the Repair Department.
Leadwires
A. Verify connection is secure.
B. Turn down the intensity. Rotate leadwires in socket 90 degrees.
If still intermittent, replace leadwire. If still intermittent after replacing
the leadwire, a component may have failed. Call the Repair
Department.
Intermittent
program in
use
Some programs will seem intermittent. This is expected.
Refer to section 6.1 for a description of the Programs.
Settings and
Electrodes
positioning
A. Check that all the settings are correct and ensure the electrodes
are positioned properly.
B. Change the positioning of the electrodes slightly.
Intermittent
Output
Stimulation is
not producing
the usual
sensation
A. Replace.
B. Reposition electrode. Electrodes must be a minimum of 2 inches
apart.
Phoenix User’s Manual
25
To self-test for any of the above, perform the following steps:
1.Place new batteries in the device.
2. Verify the device is off.
3. Insert one new lead wire into two new
electrodes.
4. Place the new electrodes on your forearm
as shown in Figure A.
5. Insert the lead wire in Channel 1.
6. Turn your device on.
7. Select program P3 (TENS). This is a
Figure A
continuous treatment program.
8. Slowly increase the amplitude (intensity) until you can feel it. If you do not get any
sensation, lower the amplitude (intensity) to zero and rotate the lead wire 90 degrees.
Slowly increase the amplitude (intensity).
9. If there is no sensation, call the Repair Department.
10. If sensation is felt, even if weak, the device is working properly. You may need to
reposition the electrodes or contact your clinician.
11. Repeat Steps 1 through 10 for Channel 2.
9. Device Maintenance
9.1 Service
Please contact Empi at the numbers below if you need assistance setting up, using, or
maintaining the Phoenix System or to report any unexpected operation or events.
For clinical questions, contact the Professional Services Department at 800.328.2536 or
651.415.9000.
If any component of the Phoenix System is not functioning properly or requires servicing,
contact the Empi Repair Department at 800.862.2343 or 605.874.6965.
When returning any products, please include your name, address, phone number and a
description of the problem.
Return to: Empi
Attn: Repair Department
47492 SD Hwy 22
Clear Lake, SD 57226 USA
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.
Do not sterilize the stimulator. Do not immerse in liquids.
Your stimulator does not require calibration. Each Empi Phoenix stimulator is tested prior to
distribution. Its characteristics do not vary under normal conditions.
26
Phoenix User’s Manual
9.3 Repair
There are no user serviceable parts inside the device. If the device appears to be nonfunctional, contact your clinician, or contact Empi directly at 800.862.2343.
Do not attempt to repair the stimulator or any of its accessories. Never dismantle the Empi
Phoenix device because of risk of electric shock. Empi, Inc. declines all responsibilities for any
damages or consequences resulting from unauthorized attempts to open, modify, or repair the
stimulator. This may only be done by persons or repair services authorized by Empi, Inc.
9.4 Operating Conditions
The Empi Phoenix device should be operated in temperatures between 50°F and 104°F (10°C
and 40°C), atmospheric pressures between 50 and 106 kPa, and relative humidity between
30% and 75%.
9.5 Transportation and Storage Conditions
The Empi Phoenix device should be transported and stored in temperatures between -40 °F
and 158 °F (-40 °C and 70 °C), atmospheric pressures between 50 and 106 kPa and relative
humidity between 10% and 90%.
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.
The Empi Phoenix device is electronic equipment and may include substances that can
damage the environment. DO NOT dispose of the device in municipal waste. Please deliver
the device to a suitable collection point for recycling of electronic equipment or contact the
Empi Repair Department (see Service section) to return it for recycling. By doing so, you will
be contributing to the safeguarding of natural resources and health.
Please dispose of batteries in compliance with relevant national or state regulatory
requirements. Do not puncture. Do not dispose in fire or incinerate.
When the electrodes no longer stick well to your skin, dispose of them in a receptacle out of
reach of children and pets.
10. Ordering Information
To order replacement electrodes, leadwires, or other accessories for your Empi Phoenix
device, contact Empi Patient Care at 800.328.2536, ext. 8455. See Section 7.2 for Empi
Phoenix Kit components.
Phoenix User’s Manual
27
11. Clinician Only Section
This section is only intended for clinicians and the functions described in this section should
not be operated by the patient.
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
continuously push on the Program Decrease
, Left
Decrease Intensity
and Right Decrease Intensity
buttons while you are in the Program Selection mode.
In the compliance screen, you will see the total time spent
in each of the programs by switching between the different
programs (for this, use the P- and P+ keys).
P3 12:36
HOURS
MINUTES
Note: Timer indicates hours and minutes instead of minutes and seconds when you are in the
Compliance screen.
Compliance counters reset
To reset the compliance counters, press continuously and simultaneously for more than 3
seconds the Program Decrease
, Left and right Decrease intensity
(same key combination
as to access the compliance screen).
To exit the compliance screen, switch Off the device by pressing the ON/OFF
28
switch.
Phoenix User’s Manual
11.2 Program Lock
You can lock the Empi Phoenix into a specific program. This
will limit the use of the device in this specific program without
the possibility for the patient to access any other program.
To lock the device
1. Select the program you want to lock the device into
when you are in the Program Selection screen.
2. Push continuously and simultaneously on the Program
Increase
, Program Decrease
and Right
Decrease
buttons.
3. The Program Lock symbol will appear. The lock setting is
kept in memory when you turn off the device.
To unlock the device
Push continuously and simultaneously on the Program Increase
, Program Decrease
and 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
29
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. Empi, Inc. warrants to the initial Purchaser (“Purchaser”) (and to no other person) that
the Product (with the exclusion of accessories such as chargers, rechargeable batteries,
electrodes, lead wires, tape adhesive patches and electrode cream) and the component
parts thereof, distributed or manufactured by Empi, Inc., shall be free from defects in the
workmanship and materials for three years from the initial date of purchase from Empi,
Inc. (the “Warranty Period”).
B. Accessories including, but not limited to, chargers, rechargeable batteries, electrodes,
lead wires, tape adhesive patches and electrode cream are excluded from the Warranty
and sold “AS IS” because their structure is such that they may be easily damaged before
or during use.
Limitation of Liabilities and Disclaimer or Warranties
A. Empi, Inc.’s sole obligation in the case of any breach of its warranties set forth in
Paragraph A in the Warranty section above, shall be, at Empi, Inc.’s option, to repair or
replace the Product without charge to Purchaser or to refund the purchase price of the
Product. In order to recover under this Warranty, Purchaser must send Empi, Inc. written
notice of the defect (setting forth the problem in reasonable detail) prior to expiration of the
Warranty Period and within 30 days of discovery of the defect. Upon Empi, Inc.’s written
request and authorization, Purchaser shall return the Product to Empi, Inc., freight and
insurance prepaid, for inspection. Notice and return shipment shall be sent to Empi, Inc.
at 47492 Hwy. 22, Clear Lake, South Dakota 57226, USA, or to an Empi, Inc. Authorized
Service Center. To locate the appropriate Service Center outside of North America, or to
request shipment approval, contact Empi, Inc. directly. Empi, Inc. will not be responsible
for damage due to improper packaging or shipment. If Empi, Inc. determines in its sole
reasonable discretion that the Product contains defective workmanship or materials,
Empi, Inc. will refund to the Purchaser, the purchase price for the defective product, or
return the repaired Product or a replacement thereof to Purchaser, the purchase price for
the defective product, or return the insurance prepaid, as soon as reasonably possible
following receipt of the Product by Empi, Inc.. Empi, Inc. determines in its sole reasonable
discretion that the Product does not contain defective workmanship or materials, Empi,
Inc. will return the Product to the Purchaser, freight and insurance billed to the Purchaser.
B. This Warranty is voided immediately as to any Product which has been repaired or
modified by any person other than authorized employees or agents of Empi, Inc. or which
has been subjected to misuse, abuse, neglect, damage in transit, accident or negligence.
30
Phoenix User’s Manual
C. Except as provided in paragraph A, the product is being sold on an as is basis, all
accessories are sold as is, and the entire risk as to the quality and performance of the
product is with purchaser. The warranty provided in paragraph A is intended solely for the
benefit of the initial purchaser and Empi, Inc. disclaims all other warranties, express or
implied including, but not limited to, any implied warranties of merchantability and fitness
for a particular purpose; provided, however, that notwithstanding the foregoing sentence,
in the event an implied warranty is determined to exist, the period for performance by
Empi, Inc. thereunder shall be limited to the lifetime of the initial purchaser. No employee,
representative or agent of Empi, Inc. has any authority to bind Empi, Inc. to any
affirmation, representation or warranty except as stated in this written warranty policy.
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. (e.g. contract, negligence or
otherwise) the remedy provided in paragraph A above shall constitute purchaser’s sole
remedy. In no event shall Empi, Inc.’s liability under any cause of action relating to the
product exceed the purchase price of the product. This Warranty gives the purchaser
specific legal rights and Purchaser may also have other rights which vary from state to
state. Some states do not allow limitations of how long an implied warranty lasts, so the
above limitation may not apply to the Purchaser.
Phoenix User’s Manual
31
13. Technical Specifications
Standard Measurement Conditions
• Temperature - 25°C +/-5°C
• Load Range - 500 Ohms - 1 kOhms
• Power Supply - 3.0V DC +/-10%
Output Waveforms
The following are theoretical standard measurement output current across purely resistive
loads at maximum intensity setting. 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. Your output may vary depending on parameter settings.
P1 Endurance Program
P3 Modulated TENS Program
Maximum Intensity: 520 Energy levels,
corresponding to 100 mA intensity and 300 μs
pulse width
Maximum Intensity: 100 mA
Zero net DC component
Zero net DC component
Maximum charge per pulse: 2 x 8 μC
Maximum charge per pulse: 2 x 30 μC
P2 Strength Program
Maximum Intensity: 520 Energy levels,
corresponding to 100 mA intensity and 300 μs
pulse width
Zero net DC component
P4 Edema Program
Maximum Intensity: 100 mA
DC component: 266 μA, independent of the set
intensity as long as the set intensity is above 4 mA.
Maximum charge per pulse: 7.2 μC for the
positive pulse and 6 μC for the negative pulse
Maximum charge per pulse: 2 x 30 μC
32
Phoenix User’s Manual
Low Voltage Indication
• Indicator Threshold: 2.3 Volts (typical)
• Shutdown Voltage: 1.95 Volts (typical)
• These voltages may be tested under NO load condition.
Fuse Characteristics
6V, 1.5 A, Resettable, breaking capacity 3A
Physical Characteristics
• Size (without belt clip): 5.4” x 2.6” x 1.2”
• Weight (with batteries and belt clip): ~ 6 ounces
• Operational Temperature: 10°C to 40°C
• Humidity (maximum): 75% RH
EN 60601-1 Classification
• 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
33
14. Guidance and Manufacturer’s
Declaration – Electromagnetic
Emissions
• The Empi Phoenix device needs special EMC precautions and must be installed and
started according to the EMC information supplied in this manual.
• Portable and mobile RF communications equipment could affect the Empi Phoenix device.
For example mobile phones can affect the Empi Phoenix device. Avoid placing a mobile
phone is direct proximity to the Empi Phoenix device.
• Warning: The use of accessories, other than those recommended by the manufacturer,
may result in stronger emissions or reduce the immunity of the 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.
• Meeting the emissions levels shown in the first table is considered to be essential
performance of the Empi Phoenix device.
GUIDANCE AND MANUFACTURER’S DECLARATION –
ELECTROMAGNETIC EMISSIONS
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
Emissions test
Compliance
Electromagnetic environment - guide
RF emissions
CISPR 11
Group 1
The Empi Phoenix uses RF energy only for its
internal function. Therefore, its RF
emissions are very low and are not likely to
cause any interference in nearby electronic
equipment.
RF emissions
CISPR 11
Class B
Empi Phoenix is suitable for use in any
establishment, other than a private dwelling or
a place connected directly to the low voltage
mains supply which powers residential buildings.
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
emission oscillations
IEC 61000-3-3
34
Not applicable,
battery
powered
Not applicable,
battery
powered
Phoenix User’s Manual
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
Immunity test
Electrostatic
discharge
(DES)
Test level IEC
60601
Compliance
level
±6 kV contact
±6 kV contact
±8 kV air
±8 kV air
CEI 61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
±2 kV for power
supply lines
±1 kV for input/
output lines
±1 kV differential
mode
±2 kV common
mode
Not Applicable –
Battery powered
Not Applicable –
signal lines less
then 3 meters
Electromagnetic environment recommendations
Floors should be wood, concrete
or ceramic tile. If floors are
covered with synthetic material,
the relative humidity should be at
least 30 %.
Mains power quality should be
that of a typical commercial or
hospital environment.
Not Applicable –
Battery powered
Mains power quality should be
that of a typical commercial or
hospital environment.
Not Applicable –
Battery powered
Mains power quality should be
that of a typical commercial or
hospital environment. If the user
of the Phoenix requires continued
operation during power mains
interruptions, it is recommended
that the Empi Phoenix be powered
from an uninterruptible power
supply or a battery.
3A/m
Power frequency magnetic fields
should be at levels characteristic
of a typical location in a
typical commercial or hospital
environment.
<5 % UT
(>95 % dip in
UT) for 0,5 cycle
Voltage
dips, short
interruptions
and
voltage
variations on
power supply
input
lines IEC
61000-4-11
Power
frequency
(50/60 Hz)
magnetic
field IEC
61000-4-8
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in
UT) for 5 sec
3 A/m
NOTE: UT is the a.c. mains voltage prior to application of the test level.
Phoenix User’s Manual
35
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.
Immunity test
Conducted RF
IEC 61000-4-6
IEC 60601 test
level
3 Vrms
150 kHz to 80
MHz
Compliance
level
3 Vrms
Electromagnetic environment recommendations
Portable and mobile RF communication
equipment should be used no closer to
any part of the Empi Phoenix device,
including cables, than recommended
separation distance calculated from the
equation applicable to the frequency of
the transmitter.
Recommended separation
distances
d = 1.2 √P
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2.5
GHz
3 V/m
d = 1.2 √P 80 MHz to 800 MHz
d = 2.3 √P 800 MHz to 2.5 GHz
where P is the maximum output
power of the transmitter in watts
(W) according to the transmitter
manufacturer and where d is the
recommended separation distance in
metres (m).
The field strength from fixed RF
transmitters, as determined by an
electromagnetic survey a should be
less than the compliance level in each
frequency range b.
Interference may occur in the vicinity of
equipment marked with the following
symbol:
NOTE 1 At 80 MHz and at 800 MHz ,the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which
the Empi Phoenix device is used exceeds the applicable RF compliance level above, the Empi Phoenix
device should be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as re‐orienting or relocating the Empi Phoenix device.
a
b
36
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 1 V/m.
Phoenix User’s Manual
RECOMMENDED SEPARATION DISTANCES BETWEEN
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
portable and mobile RF communications equipment (transmitters) and the Empi Phoenix
as recommended below, according to the maximum output power of the communications
equipment.
Rated
maximum
output
power of
transmitter
Separation distances according to frequency of the transmitter
m
From 150 kHz to
80 MHz
From 80 kHz to
800 MHz
From 800 MHz to
2.5 GHz
W
d = 1.2 √P
d = 1.2 √P
d = 2.3 √P
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.20
1.20
2.30
10
3.79
3.79
7.27
100
12.00
12.00
23.00
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (m) can be estimated using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the transmitter
in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is
modified by absorption and reflection from structures, objects and people.
Phoenix User’s Manual
37
15. Additional information on
Electrode Placement for
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. Place the Channel 1 black lead over the Vastus Medialis Oblique
(VMO). The VMO is a muscle in your quadriceps that typically sits
just above and inside your kneecap.
2. Place the Channel 2 black lead over the Vastus Lateralis (VL). The
VL is the muscle in your quadriceps that sits about two inches
further up the leg from the VMO but on the outside of the leg.
3. Place the Channel 1 red lead in the middle of your quadriceps
(thigh).
4. Place the Channel 2 red lead in the middle of the upper part of
your quadriceps (thigh).
5. To use on a portion of the body other than the knee/quadriceps,
consult a clinician.
TENS Program – P3 (High Frequency TENS):
1. Place the Channel 1 black lead over the upper inside portion of
your knee.
2. Place the Channel 2 black lead over the upper outside portion of
your knee.
3. Place the Channel 1 red lead over the lower outside portion of
your knee.
4. Place the Channel 2 red lead in the lower inside portion of your
knee.
5. You should position the electrodes so they surround the area of
pain.
6. To use on a portion of the body other than the knee, consult a
clinician.
EDEMA Program – P4 (Pulsed Direct):
1. To use the Edema program, you will need the bifurcated lead and
dispersive electrode. If you did not receive these items, contact
Empi Customer Service.
2. Plug the bifurcated lead into the red leadwire on Channel 1.
3. Place the electrodes on the bifurcated lead on the inside and
outside of the affected joint.
4. Attach the large dispersive electrode to the black lead on Channel
1 and place over the upper thigh.
5. To use on a portion of the body other than the knee, consult a
clinician.
38
Phoenix User’s Manual
16. Quick Start Guide
Read full instructions before using the device.
1. Insert batteries into the device and replace the battery
cover.
2. Place electrodes or garment following healthcare provider’s
instructions. Insert the wire from the garment (if using the
garment) or electrode leadwire (if not using the garment)
by pressing the attachment into the port on the device.
3.Turn the device on by pressing the
button.
4. Select the therapy (P1 Endurance, P2 Strength, P3 TENS
or P4 Edema) prescribed by your clinician by pressing the
or
button.
5. Adjust intensity to desired level by pressing the
and
buttons for channels 1 and 2. You must select your
program before turning up the intensity. Once the intensity
is increased, the program will be locked.
NOTE: P1 and P2 begin with a two-minute Warm-Up
phase, which will count down on the screen. The WarmUp phase will cause your muscles to twitch but not
contract. Set the device intensity to a comfortable level
during 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
39
199696 Phoenix Kit
Empi, Inc.
205 Hwy 22 East
Clear Lake, SD 57226 USA
651.415.9000; 800.328.2536
360413 Rev. B © 2013, 2015 Empi, Inc.
Was this manual useful for you? yes no
Thank you for your participation!

* Your assessment is very important for improving the work of artificial intelligence, which forms the content of this project

Download PDF

advertisement