IF8100 Manual Rev 02.pub

IF8100 Manual Rev 02.pub
IF8100
Users Manual
for
Interferential
Therapy
Page 1
Contents:
About the IF8100
3
Get Started with IF8100
4
Device Controls
4
Electrodes / Skin Care / Batteries
6
Customer Service / Supplies / Support
7
Protocols
8
Indications / Contraindications
23
Trouble Shooting
26
Technical Specifications
27
Page 2
About the IF8100
Interferential stimulation is used for a wide range of applications, generally
with the purpose of either pain relief and/or muscle stimulation. Interferential
stimulation differs from other types of electrical stimulation by its frequency
and the principle of “interference”. A substantially higher frequency (4,000
Hz) than traditional stimulation (1-150 Hz), allows the applied stimulation to
penetrate the skin with less resistance. The skin impedance is approximately
100 times less than with using traditional TENS and NMES devices. The
theory is that the more of the stimulation energy reaches the nerve and muscle
fibers and hence becomes more “productive”.
Applying two channels of 4,000 Hz stimulation in a cross pattern allows the
center of the cross to beat with the interferential frequency (f1 minus f2). This
is felt below the skin as a beating, pulsating feeling when the interferential
frequency is set below 20 Hz. Above 20 Hz the fast beating will just feel like
constant stimulation.
“I/F (Interferential) stimulation is a constant stimulation and is indicated for
symptomatic relief of chronic intractable pain, post-traumatic and post-surgical
pain. A NMES (NeuroMuscular Electrical Stimulation) Mode is available for
indications such as muscle re-education, relaxation of muscle spasms,
prevention or retardation of disuse atrophy, immediate post-surgical
stimulation of calf muscles to prevent venous thrombosis, increasing local
blood circulation, and maintaining or increasing range of motion. In the NMES
mode, the stimulation comes on in six seconds intervals, thus allowing the
muscle to rest from the contraction every six seconds.”
Important:
This device must be ordered or prescribed by a licensed physician.
Page 3
Get started with IF8100
Make sure the electrodes are placed properly on the skin (see “Electrodes and
Skin Care” for details) and that the lead wires are properly connected.
Turn on the unit by pressing ON for more than 1 second. A green or blinking
light indicates that the leads and electrodes are properly connected and that the
unit functions properly.
Begin pressing ↑ button until a comfortable level is reached, as indicated by
your physician or therapist. Stimulation will continue for 20 minutes and
automatically shut off unless the treatment timer is changed.
During treatment the display will show remaining time left on upper line and
stimulation level on lower line. The green light will be flashing with the set
Interferential frequency (f.ex. 1 pulse per second.)
To stop treatment, pressing and hold the ↓ button until display turns off.
Thereafter, remove the electrodes and place them on the plastic sheet and seal
them in the plastic bag.
Interferential stimulation at 4000 Hz consumes more energy than regular
stimulation at lower frequency. It is therefore recommended to use the
optional A/C adaptor for continued use.
Controls and Features
Turn unit ON and OFF: Press ↑ button for 1 second to turn the unit on. The
display will light up and the right LED will be flashing or constant green. Press
and hold the ↓ button to turn the unit off. It takes two additional seconds after
reaching 0 mA to turn it off. If no controls have been touched for 60 seconds
with the stimulation level at 0 mA or 60 seconds after timeout, the IF8100 will
automatically turn off.
Setting Stimulation Level: Use ↑ and ↓ buttons to increase or decrease stimulation level. Do not use the PRG button. After 20 seconds the ↑ and ↓ buttons
are electronically locked as a safety feature to prevent an unintentional increase
in stimulation. To decrease, just press ↓ button to reduce it by at least 1 mA,
which will unlock the safety feature. Thereafter, you have 20 seconds to
increase to desired stimulation level, before the lock is activated again. Any
change in stimulation level or mode will unlock the control buttons.
Page 4
Setting the Mode
Press PROG button once and use ↑ or ↓ buttons to select the desired mode:
Low Mode:
• Stimulation is present constantly during the entire treatment time.
• The interferential frequency is sweeping between 1 and 10 Hz over a
period of 15 seconds continuously.
Low-High Mode:
• Stimulation is present constantly during the entire treatment time.
• The interferential frequency is sweeping between 1 and 150 Hz over a
period of 15 seconds continuously.
High Mode:
• Stimulation is present constantly during the entire treatment time.
• The interferential frequency is sweeping between 80 and 150 Hz over a
period of 15 seconds continuously.
Muscle Mode:
• Stimulation is applied for 6 seconds, then paused for 6 seconds.
Commonly known as NeuroMuscular Electrical Stimulation (NMES). Upramp is 1 second and down-ramp is 0.5 second, fixed.
• The interferential frequency is fixed at 50 Hz.
Combo Mode:
• See the above modalities:
• 2 minutes in Low, 2 minutes in High, 2 minutes in Muscle, then repeated
until the duration of the treatment session.
Setting the Treatment Time: Press PROG two times and use ↑ or ↓ buttons to
select the desired Treatment Time. Keep pressing ↓ or ↑ button to set a
Continuous Treatment Time.
Compliance data: Press PROG three times and use ↓ button to display the
usage time in minutes and number of times used, when prompted by text in
display. Only stimulation levels above 5 mA are recorded as usage time. The
compliance meter can be reset by pressing ↑ button to show prompt in display
and thereafter press ↓ button twice to reset both parameters to zero.
Page 5
Electrodes and skincare
Proper skin care will help make the use of this device more comfortable and
trouble-free. Prior to treatment, wash the areas where the electrodes will be
placed with mild soap and water, rinse and dry the skin thoroughly. If
necessary, remove excess body hair.
The IF8100 is intended to be used with re-usable, self-adhesive electrodes.
Extended number of uses can be obtained by adding water to the adhesive
surface immediately after each use and placing them on the plastic pad. They
will regain their conductivity and adhesiveness as compared to leaving them
dry.
Sterile electrodes may be required for some post-op applications.
Batteries
One 9 volt Alkaline battery is used. The battery compartment on the back of
the device opens by sliding the cover downwards. Please ensure to dispose of
the used batteries properly.
Rechargeable batteries are not recommended as they only have a short
usage time and are not charged while in the device.
Page 6
Zynex Medical
Contact Information
CUSTOMER SERVICE
(866) 940-7030
Supplies:
To order more electrodes or other accessories
Technical Support:
Questions or problems with using your device
Device Return:
Order a postage paid return envelope to return your
device at no charge
MAIN OFFICE
Billing Questions:
(800) 495-6670
Questions regarding insurance benefits and
covered benefits for durable medical equipment or
questions about an Explanation of Benefits form
you received in the mail
FAX NUMBER
(800) 495-6695
MAILING ADDRESS
Zynex Medical
9990 Park Meadows Drive
Lone Tree, CO 80124
EMAIL
[email protected]
WEBSITE
zynexmed.com
Page 7
PAIN RELIEF & EDEMA REDUCTION
ELECTRODE PLACEMENT:
When applying electrodes in the operating room, sterile electrodes must be
used and placed away from incisions as shown below. Electrodes applied
outside the operating room do not need to be sterile and should be placed
around the bandaged area in the pattern shown below.
INTENSITY LEVEL:
Set the amplitude as high as possible without pain or muscle contraction
TREATMENT TIME & FREQUENCY:
Phase One for 15 minutes followed by Phase Two for 15 minutes (3x/day)
TREATMENT PHASE ONE
RECOMMENDED MODE:
Press Prog.
LOW
Button then Up
Button and Choose LOW
The IF frequency is sweeping between 1 Hz and 10 Hz over
a period of 15 seconds continuously.
10 Hz
10 Hz
10 Hz
1 Hz
1 Hz
1 Hz
1 Hz
15 Seconds
15 Seconds
15 Seconds
TREATMENT PHASE TWO
RECOMMENDED MODE:
HIGH
The IF frequency is sweeping between 80 Hz and 150 Hz
over a period of 15 seconds continuously.
150 Hz
80 Hz
150 Hz
80 Hz
80 Hz
15 Seconds
150 Hz
15 Seconds
80 Hz
15 Seconds
Protocol based on the following study: The Effects of Home Interferential Therapy on Post-Operative
Pain, Edema, and Range of Motion of the Knee, by Gregg J. Jarit, MD, Karen J. Mohr, PT, SCS,
Robert Waller, BS and Ronald E. Glousman, MD Published in Clinical Journal of Sports Medicine,
13:16-20 © 2003 Lippincott Williams & Wilkins, Inc, Philadelphia
Page 8
Spasm Reduction
ELECTRODE PLACEMENT:
Place 4 electrodes surrounding the affected area with the black leads opposite
of each other as shown below
INTENSITY LEVEL:
Use
button to set level to a strong, but comfortable strength. The
timer will automatically turn off stimulation after user’s preset time.
TREATMENT TIME & FREQUENCY:
Push Prog.
Button until “Timer” is in display. Use
treatment time between 30 - 60 minutes. (3x per day)
RECOMMENDED MODE:
Press Prog.
button to set
MUSCLE MODE
Button then Up
Button and Choose MUSCLE
1.0
se
c
1.0
6 Sec Off
Page 9
50 Hz
6 Sec On
sec
6 Sec On
sec
50 Hz
0.5
0.5
se
c
The stimulation is delivered at 50 Hz, On 6 Seconds, Off 6
seconds, ramp up is 1.0 second, ramp down is 0.5 second.
PAIN RELIEF
ELECTRODE PLACEMENT:
Place 4 electrodes as shown with the black leads opposite of each other
RECOMMENDED MODE:
Press Prog.
LOW-HIGH
button then up
button and choose LOW-HIGH
The IF frequency is sweeping between 1 Hz and 150 Hz
over a period of 15 seconds continuously.
150 Hz
150 Hz
1 Hz
150 Hz
1 Hz
1 Hz
1 Hz
15 Seconds
15 Seconds
15 Seconds
ALTERNATIVE MODE:
HIGH - The IF frequency is sweeping between 80 Hz and 150 Hz every 15
seconds continuously
INTENSITY LEVEL:
Use
button to set level to a strong, but comfortable strength. The
timer will automatically turn off stimulation after user’s preset time.
INCREASE CIRCULATION
RECOMMENDED MODE:
LOW - The IF frequency is sweeping
from 1 Hz to 10 Hz every 15 seconds
continuously
Dorsal View
Same wrist
INTENSITY LEVEL:
Use
button to set level to a
strong, but comfortable strength. A slight
muscle twitch may enhance blood
circulation to the area.
Palmar View
same wrist
Interferential Treatment: Usual treatment time is 20-30 minutes 3x per day;
Max is 3 hours of use within a 24 hour period
Page 10
PAIN RELIEF
ELECTRODE PLACEMENT:
Place 4 electrodes as shown with the black leads opposite of each other
RECOMMENDED MODE:
Press Prog.
LOW-HIGH
button then up
button and choose LOW-HIGH
The IF frequency is sweeping between 1 Hz and 150 Hz
over a period of 15 seconds continuously.
150 Hz
150 Hz
1 Hz
150 Hz
1 Hz
1 Hz
1 Hz
15 Seconds
15 Seconds
15 Seconds
ALTERNATIVE MODE:
HIGH - The IF frequency is sweeping between 80 Hz and 150 Hz every 15
seconds continuously
INTENSITY LEVEL:
Use
button to set level to a strong, but comfortable strength. The
timer will automatically turn off stimulation after user’s preset time.
INCREASE CIRCULATION
RECOMMENDED MODE:
LOW - The IF frequency is sweeping
from 1 Hz to 10 Hz every 15 seconds
continuously
INTENSITY LEVEL:
Use
button to set level to a
strong, but comfortable strength. A slight
muscle twitch may enhance blood
circulation to the area.
Interferential Treatment: Usual treatment time is 20-30 minutes
3x per day; Max is 3 hours of use within a 24 hour period
Page 11
PAIN RELIEF
ELECTRODE PLACEMENT:
Place 4 electrodes as shown with the black leads opposite of each other
RECOMMENDED MODE:
Press Prog.
LOW-HIGH
button then up
button and choose LOW-HIGH
The IF frequency is sweeping between 1 Hz and 150 Hz
over a period of 15 seconds continuously.
150 Hz
150 Hz
1 Hz
150 Hz
1 Hz
1 Hz
1 Hz
15 Seconds
15 Seconds
15 Seconds
ALTERNATIVE MODE:
LOW - The IF frequency is sweeping from 1 Hz to 10 Hz every 15 seconds
continuously
INTENSITY LEVEL:
Use
button to set level to a strong, but comfortable strength. The
timer will automatically turn off stimulation after user’s preset time.
INCREASE CIRCULATION
RECOMMENDED MODE:
COMBO - Combination Low Mode
(1-10 Hz), High-Mode (80-150 Hz), and
Muscle Mode ( 6 sec. On & 6 Sec. Off)
INTENSITY LEVEL:
Use
button to set level to a
strong, but comfortable strength. A slight
muscle twitch may enhance blood
circulation to the area.
Interferential Treatment: Usual treatment time is 20-30 minutes
3x per day; Max is 3 hours of use within a 24 hour period
Page 12
PAIN RELIEF
ELECTRODE PLACEMENT:
Place 4 electrodes as shown with the black leads opposite of each other
RECOMMENDED MODE:
Press Prog.
LOW-HIGH
button then up
button and choose LOW-HIGH
The IF frequency is sweeping between 1 Hz and 150 Hz
over a period of 15 seconds continuously.
150 Hz
150 Hz
1 Hz
150 Hz
1 Hz
1 Hz
1 Hz
15 Seconds
15 Seconds
15 Seconds
ALTERNATIVE MODE:
LOW - The IF frequency is sweeping from 1 Hz to 10 Hz every 15 seconds
continuously
INTENSITY LEVEL:
Use
button to set level to a strong, but comfortable strength. The
timer will automatically turn off stimulation after user’s preset time.
INCREASE CIRCULATION
RECOMMENDED MODE:
COMBO - Combination Low Mode
(1-10 Hz), High-Mode (80-150 Hz), and
Muscle Mode ( 6 sec. On & 6 Sec. Off)
INTENSITY LEVEL:
Use
button to set level to a
strong, but comfortable strength. A slight
muscle twitch may enhance blood
circulation to the area.
Interferential Treatment: Usual treatment time is 20-30 minutes
3x per day; Max is 3 hours of use within a 24 hour period
Page 13
PAIN RELIEF
ELECTRODE PLACEMENT:
Place 4 electrodes as shown with the black leads opposite of each other
RECOMMENDED MODE:
Press Prog.
LOW-HIGH
button then up
button and choose LOW-HIGH
The IF frequency is sweeping between 1 Hz and 150 Hz
over a period of 15 seconds continuously.
150 Hz
150 Hz
1 Hz
150 Hz
1 Hz
1 Hz
1 Hz
15 Seconds
15 Seconds
15 Seconds
ALTERNATIVE MODE:
HIGH - The IF frequency is sweeping between 80 Hz and 150 Hz every 15
seconds continuously
INTENSITY LEVEL:
Use
button to set level to a strong, but comfortable strength. The
timer will automatically turn off stimulation after user’s preset time.
INCREASE CIRCULATION
RECOMMENDED MODE:
COMBO - Combination Low Mode
(1-10 Hz), High-Mode (80-150 Hz), and
Muscle Mode ( 6 sec. On & 6 Sec. Off)
INTENSITY LEVEL:
Use
button to set level to a
strong, but comfortable strength. A slight
muscle twitch may enhance blood
circulation to the area.
Interferential Treatment: Usual treatment time is 20-30 minutes 3x per day;
Max is 3 hours of use within a 24 hour period
Page 14
PAIN RELIEF
ELECTRODE PLACEMENT:
Place 4 electrodes as shown with the black leads opposite of each other
RECOMMENDED MODE:
Press Prog.
LOW-HIGH
button then up
button and choose LOW-HIGH
The IF frequency is sweeping between 1 Hz and 150 Hz
over a period of 15 seconds continuously.
150 Hz
150 Hz
1 Hz
150 Hz
1 Hz
1 Hz
1 Hz
15 Seconds
15 Seconds
15 Seconds
ALTERNATIVE MODE:
HIGH - The IF frequency is sweeping between 80 Hz and 150 Hz every 15
seconds continuously
INTENSITY LEVEL:
Use
button to set level to a strong, but comfortable strength. The
timer will automatically turn off stimulation after user’s preset time.
INCREASE CIRCULATION
RECOMMENDED MODE:
COMBO - Combination Low Mode
(1-10 Hz), High-Mode (80-150 Hz), and
Muscle Mode ( 6 sec. On & 6 Sec. Off)
INTENSITY LEVEL:
Use
button to set level to a
strong, but comfortable strength. A slight
muscle twitch may enhance blood
circulation to the area.
Interferential Treatment: Usual treatment time is 20-30
minutes 3x per day; Max is 3 hours of use within a 24 hour
period
Page 15
PAIN RELIEF
ELECTRODE PLACEMENT:
Place 4 electrodes as shown with the black leads opposite fo each other
RECOMMENDED MODE:
Press Prog.
HIGH
button then up
button and choose HIGH MODE
The IF frequency is sweeping between 80 Hz and 150 Hz
over a period of 15 seconds continuously.
150 Hz
80 Hz
150 Hz
80 Hz
80 Hz
15 Seconds
150 Hz
15 Seconds
80 Hz
15 Seconds
ALTERNATIVE MODE:
LOW-HIGH - Full Sweep from 1 Hz to 150 Hz every 15 seconds
continuously
INTENSITY LEVEL:
Use
button to set level to a strong, but comfortable strength. The
timer will automatically turn off stimulation after user’s preset time.
INCREASE CIRCULATION
RECOMMENDED MODE:
LOW - The IF frequency is sweeping from 1 Hz to 10 Hz every 15
seconds continuously
Outside View
same foot
INTENSITY LEVEL:
Use
button to set level to a
strong, but comfortable strength. A
slight muscle twitch may enhance
blood circulation to the area.
Interferential Treatment: Usual treatment time is 20-30
minutes 3x per day; Max is 3 hours of use within a 24 hour
period
Page 16
Inside View
same foot
PAIN RELIEF
ELECTRODE PLACEMENT:
Place 4 electrodes as shown with the black leads opposite of each other
RECOMMENDED MODE:
Press Prog.
HIGH
Button then Up
Button and Choose HIGH MODE
The IF frequency is sweeping between 80 Hz and 150 Hz
over a period of 15 seconds continuously.
150 Hz
80 Hz
150 Hz
80 Hz
80 Hz
15 Seconds
150 Hz
15 Seconds
80 Hz
15 Seconds
ALTERNATIVE MODE:
LOW-HIGH - Full Sweep from 1 Hz to 150 Hz every 15 seconds
continuously
INTENSITY LEVEL:
Use
button to set level to a strong, but comfortable strength. The
timer will automatically turn off stimulation after user’s preset time.
INCREASE CIRCULATION
RECOMMENDED MODE:
LOW - The IF frequency is sweeping from 1 Hz to 10 Hz every 15
seconds continuously
Outside View
same foot
INTENSITY LEVEL:
Use
button to set level to a
strong, but comfortable strength. A
slight muscle twitch may enhance
blood circulation to the area.
Interferential Treatment: Usual treatment time is 20-30
minutes 3x per day; Max is 3 hours of use within a 24 hour
period
Page 17
Inside View
same foot
PAIN RELIEF
ELECTRODE PLACEMENT:
Place 4 electrodes as shown with the black leads opposite of each other
RECOMMENDED MODE:
Press Prog.
HIGH
button then up
button and choose HIGH
The IF frequency is sweeping between 80 Hz and 150 Hz
over a period of 15 seconds continuously.
150 Hz
80 Hz
150 Hz
80 Hz
80 Hz
15 Seconds
150 Hz
15 Seconds
80 Hz
15 Seconds
ALTERNATIVE MODE:
LOW-HIGH - Full Sweep from 1 Hz to 150 Hz every 15 seconds
continuously
INTENSITY LEVEL:
Use
button to set level to a strong, but comfortable strength. The
timer will automatically turn off stimulation after user’s preset time.
INCREASE CIRCULATION
RECOMMENDED MODE:
COMBO - Combination Low Mode
(1-10 Hz), High-Mode (80-150 Hz),
and Muscle Mode ( 6 sec. On & 6
Sec. Off)
Dorsal View
same arm
INTENSITY LEVEL:
Use
button to set level to a
strong, but comfortable strength. A
slight muscle twitch may enhance
blood circulation to the area.
Palmar View
same arm
Interferential Treatment: Usual treatment time is 20-30 minutes 3x per day;
Max is 3 hours of use within a 24 hour period
Page 18
PAIN RELIEF
ELECTRODE PLACEMENT:
Place 4 electrodes as shown with the black leads opposite of each other
RECOMMENDED MODE:
Press Prog.
LOW-HIGH
button then up
button and choose LOW-HIGH
The IF frequency is sweeping between 1 Hz and 150 Hz
over a period of 15 seconds continuously.
150 Hz
150 Hz
1 Hz
150 Hz
1 Hz
1 Hz
1 Hz
15 Seconds
15 Seconds
15 Seconds
ALTERNATIVE MODE:
HIGH - The IF frequency is sweeping between 80 Hz and 150 Hz every 15
seconds continuously
INTENSITY LEVEL:
Use
button to set level to a strong, but comfortable strength. The
timer will automatically turn off stimulation after user’s preset time.
INCREASE CIRCULATION
Inside View
same leg
RECOMMENDED MODE:
COMBO - Combination Low Mode
(1-10 Hz), High-Mode (80-150 Hz), and
Muscle Mode ( 6 sec. On & 6 Sec. Off)
INTENSITY LEVEL:
Use
button to set level to a
strong, but comfortable strength. A slight
muscle twitch may enhance blood
circulation to the area.
Interferential Treatment: Usual treatment time is 20-30 minutes 3x per day;
Max is 3 hours of use within a 24 hour period
Page 19
Outside View
same leg
PAIN RELIEF
ELECTRODE PLACEMENT:
Place 4 electrodes as shown with the black leads opposite of each other
RECOMMENDED MODE:
Press Prog.
LOW-HIGH
button then up
button and choose LOW-HIGH
The IF frequency is sweeping between 1 Hz and 150 Hz
over a period of 15 seconds continuously.
150 Hz
150 Hz
1 Hz
150 Hz
1 Hz
1 Hz
1 Hz
15 Seconds
15 Seconds
15 Seconds
ALTERNATIVE MODE:
HIGH - The IF frequency is sweeping between 80 Hz and 150 Hz every 15
seconds continuously
INTENSITY LEVEL:
Use
button to set level to a strong, but comfortable strength. The
timer will automatically turn off stimulation after user’s preset time.
INCREASE CIRCULATION
RECOMMENDED MODE:
COMBO - Combination Low Mode
(1-10 Hz), High-Mode (80-150 Hz), and
Muscle Mode ( 6 sec. On & 6 Sec. Off)
INTENSITY LEVEL:
Use
button to set level to a
strong, but comfortable strength. A slight
muscle twitch may enhance blood
circulation to the area.
Interferential Treatment: Usual treatment time is 20-30 minutes
3x per day; Max is 3 hours of use within a 24 hour period
Page 20
PAIN RELIEF
ELECTRODE PLACEMENT:
Place 4 electrodes as shown with the black leads opposite of each other
RECOMMENDED MODE:
Press Prog.
LOW-HIGH
button then up
button and choose LOW-HIGH
The IF frequency is sweeping between 1 Hz and 150 Hz
over a period of 15 seconds continuously.
150 Hz
150 Hz
1 Hz
150 Hz
1 Hz
1 Hz
1 Hz
15 Seconds
15 Seconds
15 Seconds
ALTERNATIVE MODE:
HIGH - The IF frequency is sweeping between 80 Hz and 150 Hz every 15
seconds continuously
INTENSITY LEVEL:
Use
button to set level to a strong, but comfortable strength. The
timer will automatically turn off stimulation after user’s preset time.
INCREASE CIRCULATION
RECOMMENDED MODE:
COMBO - Combination Low Mode
(1-10 Hz), High-Mode (80-150 Hz), and
Muscle Mode ( 6 sec. On & 6 Sec. Off)
INTENSITY LEVEL:
Use
button to set level to a
strong, but comfortable strength. A slight
muscle twitch may enhance blood
circulation to the area.
Interferential Treatment: Usual treatment time is 20-30 minutes
3x per day; Max is 3 hours of use within a 24 hour period
Page 21
PAIN RELIEF
ELECTRODE PLACEMENT:
Place 4 electrodes as shown with the black leads opposite to each other
RECOMMENDED MODE:
Press Prog.
HIGH
Button then Up
Button and Choose HIGH
The IF frequency is sweeping between 80 Hz and 150 Hz
over a period of 15 seconds continuously.
150 Hz
80 Hz
150 Hz
80 Hz
80 Hz
15 Seconds
150 Hz
15 Seconds
80 Hz
15 Seconds
ALTERNATIVE MODE:
LOW-HIGH - Full Sweep from 1 Hz to 150 Hz every 15 seconds
continuously
INTENSITY LEVEL:
Use
button to set level to a strong, but comfortable strength. The
timer will automatically turn off stimulation after user’s preset time.
Interferential Treatment: Usual treatment time is 20-30 minutes 3x per day;
Max is 3 hours of use within a 24 hour period
Page 22
Indications, contraindications, precautions, safety and warnings.
Safety References
Zynex Medical (Zynex) is only responsible for the safety, reliability and function of the device when repairs, adjustments and changes have been carried out
by persons authorized by Zynex for such work and the device is used according to the user manual. Repairs and technical safety tests shall only be carried
out by trained personnel.
Indications
This Zynex device has been designed for muscle re-education, prevention of
retardation of disuse atrophy, increase local blood circulation, maintain or increase range of motion, relaxation of muscle spasms and edema reduction.
Symptomatic relief of chronic intractable pain, post-traumatic and postsurgical pain. (IF Mode)
Relaxation of muscle spasms.
Prevention of retardation of disuse atrophy.
Increasing local blood circulation.
Muscle re-education.
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
Maintaining or increasing range of motion.
This stimulator should only be used under supervision for adjunctive therapy
for the treatment of medical diseases and conditions.
Contraindications
•
•
•
This stimulator should not be used on patients with a cardiac demand
pacemakers.
Electrodes should not be placed so that current will be applied to the carotid sinus (neck) region or transcerebally (through the head).
This stimulator should not be used whenever pain syndromes are undiagnosed, until etiology is established. (In I/F Mode)
Page 23
Warnings
In I/F Modes
•
•
•
•
•
•
•
The safety of tens devices for use during pregnancy or birth has not been
established.
This device is not effective for pain of central origin. (This includes
headache)
This device should only be used under the continued supervision of a
physician.
This device does not have curative value.
This device offers symptomatic treatment such as suppressing the sensation of pain which would otherwise serve as a protective mechanism.
The user must keep the device out of the reach of children.
Electronic monitoring equipment (such as ECG monitors and ECG alarms)
may not operate properly when this device is in use.
In Muscle Mode:
•
•
•
•
•
•
•
The long-term effects of chronic electrical stimulation are unknown.
Stimulation should not be applied over the carotid sinus nerves,
particularly in patients with known sensitivity to the carotid sinus reflex.
Stimulation should not be applied over the neck or mouth. Severe spasm
of the laryngeal and pharyngeal muscles may occur and the contractions
may be strong enough to close the airway or cause difficulty in breathing.
Stimulation should not be applied transthoracically in that the introduction
of electrical current into the heart may cause cardiac arrhythmias.
Stimulation should not be applied transcerebrally.
Stimulation should not be applied over swollen, infected, or inflamed
areas of skin eruptions, e.g. phlebitis, thrombophlebitis, varicose veins,
etc.
Stimulation should not be applied over, or in proximity to, cancerous
lesions.
Page 24
Precautions
For the I/F Modes:
•
•
Isolated cases of skin irritation may occur at the site of the electrode
placement following long-term application.
Effectiveness is highly dependent upon patient selection by a person
qualified in management of pain patients.
For the NMES Mode:
•
•
•
•
•
•
•
•
•
Safety of powered muscle stimulators for use during pregnancy has
not been established.
Caution should be used for patients with suspected or diagnosed heart
problems.
Caution should be used for patients with suspected or diagnosed
epilepsy.
Caution should be used in the presence of the following:
1. When there is a tendency to hemorrhage following acute
trauma or fracture;
2. Following recent surgical procedures when muscle
contraction may disrupt the healing process:
3. Over the menstruating or pregnant uterus; and
4. Over the areas of the skin which lack normal sensation.
Some patients may experience skin irritation or hypersensitivity due
to the electrical stimulation or electrical conductive medium. The
irritation can usually be reduced by using an alternate conductive
medium, or alternate electrode placement.
Electrode placement and stimulation settings should be based on the
guidance of the prescribing practitioner.
This device should be kept out of reach of children.
This device should be used only with the leads and electrodes
recommended for use by the manufacturer.
This device should not be used while driving, operating machinery, or
during any activity in which voluntary muscle contractions may put
the user at undue risk of injury.
Adverse Reactions:
Skin irritation and burns beneath the electrodes are potential adverse
reactions.
Page 25
Trouble-shooting
Problem
Unit stays on – even
after treatment ends.
Hold Off button down for 2 seconds to shut unit off –
else unit will shut off automatically after 5 minutes of
no stimulation. Alternatively you can start a new treatment session now, without having to start from scratch.
Can not increase
Turn level down 1 mA to unlock this safety feature –
level from its current then turn it up to the desired level/intensity. Intensity
setting.
level is always locked after 20 seconds of no change of
settings.
Do not feel the
Check that the lead wires are connected correctly to
traditional I/F beat in the electrodes (red opposite to each other, black
the center of the four opposite to each other)
electrodes.
Display shows
electrode alarm.
Check your electrodes, they must be fresh and stick
well. Then check your electrodes again, possibly
change to new electrodes. Then check that all four
electrodes are connected to lead wires and that both
lead wires are connected to the unit. Eventually put all
four metal pins together to short-circuit the
outputs – that should make the electrode alarm go
away – and thereby prove that the problem IS the electrode quality.
Page 26
Technical specifications:
Carrier frequency:
4000 Hz nominal
Modulation frequency:
Continuous 4001-4150 Hz,
freq. Shift modes 4001-4240 Hz
I/F Modes:
Low, Low-High, High.
Muscle Mode:
50 Hz, 6 sec. On, 6 sec. Off.
Up-ramp is 1.0 sec. and down-ramp is
0.5 sec.
Treatment timer:
Continuous, 10-100 minutes, in 10
minutes steps. Factory setting is 20
minutes.
Compliance meter:
Records total usage time in minutes
and number of times used.
Can be reset.
Dimensions:
4.5 x 2.5 x 0.9 in.
Weight:
5 oz. Incl. Battery
Warranty:
3 Years manufacturers warranty on
materials and workmanship.
Accessories excluded.
Page 27
8022 SouthPark Circle Littleton, CO 80120
800-495-6670 www.zynexmed.com
Page 28
P/N 300201 REV 02
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