Zynex Medical NexWave User manual

NexWave
User’s Manual

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NexWave
Table of Contents
Contact Information / Customer Service / Supplies / Support 4
About the NexWave 5
Safety Information 6
Electrodes and Lead Wires Setup 9
Programming Instructions 12
Preprogrammed Modes 13
Controls 15
Operating Instructions 16
Protocols 17
Indications, Contraindications and Warnings 32
Precautions and Adverse Reactions 41
Troubleshooting 42
Specifications and Accessories 43
Electrodes, Batteries, Cleaning 44
Warranty 45

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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 800-495-6670
303-703-4906
Billing Questions: Questions regarding insurance benefits and
covered benefits for Durable Medical Equipment
(DME) or questions about an Explanation of
Benefits form you received in the mail
FAX NUMBER 800-495-6695
303-347-9153
MAILING ADDRESS
Zynex Medical, Inc.
9555 Maroon Circle
Englewood, CO 80112
USA
EMAIL [email protected]
WEBSITE www.zynex.com
EUROPEAN REPRESENTATIVE
Zynex Europe
Faelledvej 1, Box 19 BDO
DK-5100 Odense C
Denmark

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About the NexWave
The NexWave is a multiple-mode stimulator which allows users a choice of treatment
options. This device incorporates Interferential Current (IFC), Transcutaneous
Electrical Nerve Stimulation (TENS), and Neuromuscular Electrical Stimulation
(NMES).
Interferential Current (IFC)
The left channel (channel 1) produces a signal at a frequency of 4000 Hz. A slightly
higher frequency (4001-4128 Hz) is produced by the right channel (channel 2). When
applied to the skin, the signals from the two channels “interfere” with each other, and
create a difference frequency which is felt during treatment. IFC therapy requires the
use of both channels (four electrodes).
Transcutaneous Electrical Nerve Stimulation (TENS)
TENS delivers electrical impulses through the skin in the range of 1-125 Hz. TENS
treatments can range from 10 minutes to many hours and can be applied as needed
for pain relief. Patients can use one or two channels (two or four electrodes) for TENS
therapy.
Neuromuscular Electrical Stimulation (NMES)
NMES delivers electrical impulses to muscle motor points at a frequency of 35 Hz. The
stimulation is set by the user at a level to cause muscle contraction. There are three
different programs to choose from and each program has a preset stimulation “On
Time” of 10 seconds. The “rest period” (no stimulation) varies from 10 seconds to 30
seconds depending on which program is used. The 10:10 program setting has a rest
period of 10 seconds, the 10:20 program setting has a rest period of 20 seconds, and
the 10:30 program setting has a rest period of 30 seconds. For all programs, the
stimulation ramp up time is 3 second and the ramp down is 1 seconds. Channel 1
and Channel 2 have the same “On” and “Off” Times and when used together will
operate simultaneously.
Important: This device must be ordered or prescribed by a licensed physician.

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Safety Information
 Equipment Classification
As per the International Electrotechnical Commission standard IEC 60601-1, and
the European standard EN 60601-1, Medical Electrical Equipment, General
Requirements for Basic Safety and Essential Performance, the NexWave is
classified as follows:
 Type BF Equipment
A Type BF piece of equipment is one that provides a particular degree of
protection against electric shock, particularly regarding allowable leakage
current. Type BF applied part is one that is floating above ground and is
isolated from all other parts of the equipment.
 Medical Device Directive (MDD) Classification
The NexWave a Class IIa medical device per the European Medical Device
Directive.
 Internally Powered Equipment
When the NexWave is powered by the internal, 9 VDC, MN1604, battery it is
classified as Internally Powered Equipment.
 Class II Medical Equipment
When powered by the external, 12 VDC, medical grade, power supply, the
NexWave is classified as Class II Medical Electrical (ME) Equipment. Note:
When the external power supply is connected to the NexWave device, the
power supply is considered part of the ME equipment.
 Electromagnetic Compatibility
Conforms to IEC 60601-1-2.
 Temperature
Operating temperature range: 0° - 40° C (32° - 104° F)
Storage temperature range: -20° - 70° C (-4° - 158° F)
 Water Ingress
Ordinary equipment. This device does not have protection against ingress
of water.
 Flammable Anesthetics
This device is not suitable for use in the presence of a flammable anesthetic
mixture with air, or in the presence of a flammable anesthetic mixture with
oxygen or nitrous oxide.

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Safety Information
 Mode of Operation
This device is suitable for continuous operation.
 Symbols
Safety symbols shown on this device above are defined below.
On/Off. This symbol indicates that the labeled switch electronically
cycles the DC power on and off for part of the equipment. Note: To
disconnect the external power supply, unplug the power cord of the
supplied AC adapter from the AC mains outlet.
General Warning Sign. Follow warnings stated in the instruction
manual to prevent potential hazards.
Refer to Instruction Manual/Booklet. The operator must read,
understand, and follow all instructions in the accompanying
document including all warnings, cautions, and precautions before
using this medical device.
Type BF Equipment. This symbol indicates that the patient applied
parts (electrodes) are Type BF (floating from ground) offering the user
a specific level of safety.

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Waste Electrical and Electronic Equipment (WEEE). This product
may contain substances known to be hazardous to the environment
or to human health. It should be disposed of properly (for example, at
your local waste collection administration or recycling plant) and in
accordance with local ordinances.
Service and Calibration
 Do not remove the cover. There are no user serviceable parts. Refer all
service to authorized personnel. No modification of the equipment is
allowed.
 No preventative inspections are required. Factory testing and
calibration ensure equipment accuracy and response. Contact Zynex
Medical for factory re-calibration if necessary.

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Electrode Connector Plastic Backing
Electrode
IFC modality requires all 4 electrodes
(2 channels)
TENS and NMES modalities can use 2
electrodes (1 channel) or 4 electrodes
(2 channels)
NexWave
Electrode and Lead Wire Setup
Step 1 Open electrode package and remove electrodes from package. Keep
electrodes on plastic backing.
Note: Only Zynex Medical electrodes are approved for use with the
NexWave. P/N 300027 are provided standard. Sterile electrodes, P/N
300100, are optionally available (for U.S. only). See additional accessories
on page 43.
Step 2 Insert lead wire pin connectors into electrode connectors as shown below.
RED lead wire connectors on one side and BLACK lead wire connectors on
the other side.

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NexWave
Electrode and Lead Wire Setup (continued)
Step 3 Remove each electrode from the plastic backing and place on the
treatment site according to the type of modality selected.
Electrode Arrangement
When using the IFC modality, RED and BLACK lead wires must be placed
in a crisscrossed pattern as shown in the diagram below.
TENS or NMES:
Using both channels and crisscrossing the electrodes is
optional.
IFC
Crisscrossed Pattern
TENS or NMES
Up and Down Pattern

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NexWave
Electrode and Lead Wire Setup (continued)
Step 4 Plug lead wires into the top of this device. The IFC modality
requires both lead wires to be connected (channel 1 & 2). TENS and
NMES can use 1 (Channel 1) or 2 (Channel 1 & 2) lead wires.
Step 5 Proceed to page 16 to start treatment or page 12 to program device.
Channel 2Channel 1

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NexWave
Device Programming Instructions
1. Place electrodes on the skin prior to turning on this device.
2. Turn device on by pressing the black On/Off button
3. Select desired Modality by pressing the “IFC”, “TENS”, or “NMES” button once.
4. Continue to press the selected modality button until arrow is next to desired
program.
5. Press Treatment Timer button until desired treatment time is set on screen.
Device is now ready to use.
Treatment
Timer Button
Modality
Buttons
On/Off
Button

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NexWave
Preprogrammed Modes
Interferential Current (IFC)
Mode Description
Low-High The frequency of channel 2 sweeps between 4001 Hz and 4128
Hz every 15 seconds, while the channel 1 frequency remains
fixed at 4000 Hz.
Low The frequency of channel 2 sweeps between 4001 Hz and 4010
Hz every 15 seconds, while the channel 1 frequency remains
fixed at 4000 Hz.
Combo Combo consists of three 2 minute cycles which repeat over the
duration of the treatment.
1st cycle - Low Mode: as described above.
2nd cycle - High Mode: like Low Mode, but channel 2 sweeps
between 4064 Hz and 4128 Hz.
3rd cycle - Muscle Mode: The frequency of channel 2 is fixed at
4064 Hz, and the frequency of channel 1 is fixed at 4000 Hz.
Both channels are cycled on and off simultaneously at 6 second
intervals.
Transcutaneous Electrical Nerve Stimulation (TENS)
Mode Description
Sweep The frequency is decreased linearly from 125 Hz to 11 Hz over a
4 second span. During this time, the pulse width is increased
linearly from 120 μs to 300 μs. Then the frequency is decreased
from 10 Hz to 1 Hz over a two second span. The pulse width is
constant at 300 μs. Then the frequency is increased linearly
from 1 Hz to 10 Hz over a two second span. The pulse width is
constant at 300 μs. Then the frequency is increased linearly
from 11 Hz to 125 Hz over a four second span. During this time,
the pulse width is decreased linearly from 300 μs to 120 μs.
Lmd Frequency sweeps between 66.7-100 Hz and back again over
12 seconds. Pulse width linearly decreases to 150 μs when
frequency is sweeping up and increases back up to the default
pulse width of 300 μs when frequency is sweeping down.
Hmd Same as Lmd, but with a frequency shift interval of 2 seconds.

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NexWave
Preprogrammed Modes
Neuromuscular Electrical Stimulation (NMES)
Mode Description
30:10 Preset 10 seconds on and 30 seconds off time, 35 Hz
frequency, 480 μs pulse width, 3 second ramp-up, 1 second
ramp-down, both channels cycle simultaneously.
20:10 Same as above, but with a 20 second off time.
10:10 Same as above, but with a 10 second off time.

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Uses electricity from wall
socket instead of 9 V battery
A/C Adapter Input
Channel 2 Intensity Control
Up and Down Button
Channel 1 Intensity Control
Up and Down Button
Lead Wire Connection
Channel 1
Lead Wire Connection
Channel 2
Turns Unit On/Off
On/Off Button
IFC, TENS, NMES
Modality Buttons
Unlock Button Controls
Unlock Button
Treatment Timer
Treatment Timer Button
Display
NexWave
Device Controls

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NexWave
Device Operating Instructions
Start Treatment:
Before starting treatment electrodes must be placed on the treatment site and lead
wires and electrodes connected to this device. See pages 9-11 and 17-31 for
examples.
1. Turn NexWave on by pressing On/Off button once.
2. Increase intensity by pressing Channel 1 Up button until a strong but
comfortable stimulation level is felt. Repeat for Channel 2 if both lead wires are
attached and device is in TENS or NMES mode.
3. Once desired level of stimulation is set, the unit will automatically shut off at the
preset treatment time shown on the display. If Treatment Timer has been set to
“No Timer” then this device will need to be shut off manually.
Refer to
Programming Instructions on page 12 to adjust Treatment Timer.
4. To turn off device manually, press the On/Off button.
During Treatment:
IMPORTANT: Button controls lock after 20 seconds of inactivity. To unlock button
controls, press Unlock button.
Increase Intensity:
To increase intensity, press the Up Intensity button for the desired channel until the
preferred level of stimulation is felt. While in IFC mode, pressing either Up Intensity
button will increase the stimulation level.
Decrease Intensity:
To decrease intensity, press the Down Intensity button for the desired channel until
the preferred level of stimulation is felt. While in IFC mode, pressing either Down
Intensity button will decrease the stimulation level.
Display Alerts:
Check Connections: Lead wire(s) and/or electrode(s) may not be attached properly.
Check all connections and try again (see page 42). If problem persists, call Technical
Support (see page 4).
Low Battery:Replace battery immediately or connect the A/C adapter.
Locked: Stimulation level and mode cannot be changed until Unlock button is
pressed.

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PAIN CONTROL - TENS ONLY
INTENSITY LEVEL:
The stimulation level should be set to a strong, but comfortable strength.
DEVICE SET-UP:
Modality Mode Suggested Treatment
________________________________________________________________________________________________________________________________________________________________________
TENS Swp, Lmd, Hmd As needed
Radicular Back Pain-Sciatica
ELECTRODE PLACEMENT
Place one set of electrodes for one channel close to the spine and follow the pain
route as shown below. The other channel electrodes should be placed to follow pain
route down the leg when pain is felt below the low back as show below.
Option 1 Option 2

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PAIN CONTROL
INTENSITY LEVEL:
The stimulation level should be set to a strong, but comfortable strength.
DEVICE SET-UP:
Modality Mode Treatment Time
________________________________________________________________________________________________________________________________________________________________________
IFC LoHi, Low, Cmb 40 minutes 4 times/day
TENS Swp, Lmd, Hmd As needed
ELECTRODE PLACEMENT
Electrodes should surround the targeted treatment site with area of pain located in
the center of the electrode area.
IFC Modality
Place the electrodes with the RED and
BLACK ends of the lead wires according
to pattern depicted on figure to the left.
TENS Modality
Place the electrodes with the RED and
BLACK ends of the lead wires according
to pattern depicted on figure to the left.
Using both channels and crisscrossing
the electrodes is optional when using
the TENS modality.
Lumbar Back

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PAIN CONTROL
INTENSITY LEVEL:
The stimulation level should be set to a strong, but comfortable strength.
DEVICE SET-UP:
Modality Mode Treatment Time
________________________________________________________________________________________________________________________________________________________________________
IFC LoHi, Low, Cmb 40 minutes 4 times/day
TENS Swp, Lmd, Hmd As needed
ELECTRODE PLACEMENT
Electrodes should surround the targeted treatment site with area of pain located in
the center of the electrode area.
IFC Modality
Place the electrodes with the RED and
BLACK ends of the lead wires according
to pattern depicted on figure to the left.
TENS Modality
Place the electrodes with the RED and
BLACK ends of the lead wires according
to pattern depicted on figure to the left.
Using both channels and crisscrossing
the electrodes is optional when using
the TENS modality.
Cervical / Upper Back

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PAIN CONTROL
INTENSITY LEVEL:
The stimulation level should be set to a strong, but comfortable strength.
DEVICE SET-UP:
Modality Mode Treatment Time
_______________________________________________________________________________________________________________________________________________________________________
IFC LoHi, Low, Cmb 40 minutes 4 times/day
TENS Swp, Lmd, Hmd As needed
ELECTRODE PLACEMENT
Electrodes should surround the targeted treatment site with area of pain located in
the center of the electrode area.
IFC Modality
Place the electrodes with the RED and
BLACK ends of the lead wires according
to pattern depicted on figure to the left.
Thoracic Back
TENS Modality
Place the electrodes with the RED and
BLACK ends of the lead wires according
to pattern depicted on figure to the left.
Using both channels and crisscrossing
the electrodes is optional when using
the TENS modality.