Zynex Medical NexWave User manual

48
P/N 300400, Rev.13.0
Zynex Medical, Inc.
9555 Maroon Circle
Englewood, CO 80112
USA
Phone: [phone]
Fax: [phone]
Internet: www.zynex.com
Email: [email protected]
NexWave
User’s Manual

2
47

46
3
NexWave
Table of Contents
Contact Informaon / Customer Service / Supplies / Support 4
About the NexWave 5
Safety Informaon 6
Electrodes and Lead Wires Setup 9
Programming Instrucons 12
Preprogrammed Modes 13
Controls 15
Operang Instrucons 16
Protocols 17
Indicaons, Contraindicaons and Warnings 32
Precauons and Adverse Reacons 41
Troubleshoong 42
Specicaons and Accessories 43
Electrodes, Baeries, Cleaning 44
Warranty 45

4
Zynex Medical
Contact Informaon
CUSTOMER SERVICE 800-495-6670
Supplies: To order more electrodes or other accessories
Technical Support: Quesons 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
Billing Quesons: Quesons regarding insurance benets and
covered benets for Durable Medical Equipment
(DME) or quesons about an Explanaon of
Benets form you received in the mail
FAX NUMBER 800-495-6695
855-845-5941
MAILING ADDRESS
Zynex Medical, Inc.
9555 Maroon Circle
Englewood, CO 80112
USA
EMAIL [email protected]m
WEBSITE www.zynex.com
45
NexWave
Warranty Informaon
The NexWave device is warranted to be free from defects in material, workmanship,
and structural integrity when subjected to normal domesc use and service for ve
years aer the original purchase.
During that me, Zynex Medical, Inc. will replace, at its sole discreon, the NexWave
device that has been used in a standard manner. This warranty does not cover misuse
or use contrary to the operang instrucons supplied.
Warranty obligaons are limited to replacement of defecve parts and components, at
the opon of Zynex Medical, Inc. This Warranty is only valid for the original purchaser
of this product and will not be honored if the product ownership is transferred or is
resold.
To obtain warranty service, please contact Technical Support at the number listed on
page 4 of this manual.

44
NexWave
Electrodes, Baeries, and Cleaning
Electrodes and Skin Care
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.
Sterile electrodes may be required for some post-operave applicaons.
Follow direcons of the prescribing physician.
Baery Power
One 9 V alkaline baery is used. The baery compartment on the back of this device
opens by sliding the cover downwards. Rechargeable baeries are not recommended
since they have only a short usage me and are not charged while in this device.
Replace baery when the baery icon appears on the display.
Insert the boom of the baery into the baery compartment rst, then press the
contacts into posion.
The NexWave operates normally even if the 9 V baery is inserted with reverse
polarity.
Remove baery if planning to store NexWave.
Please dispose of used baeries properly.
AC Adapter
The NexWave is supplied with an AC adapter that is plugged into the le side of this
device and then into a 120 or 230 VAC electrical outlet. Note: The supplied AC
adapter, Zynex P/N 200109, mains power requirement is 100-240 VAC, 50-60 Hz, 0.3A
maximum. While plugged in, this device is powered from the electrical outlet and not
the 9 V baery. The baery does not need to be removed while ulizing the AC
adapter.
Device Cleaning
The NexWave case and display window can be cleaned by lightly applying mild soap to
a damp so cloth or paper towel and using it to wipe the surfaces clean. Allow the
unit to dry thoroughly before using. Do not spray cleaning soluons directly onto the
unit, or immerse it in water or other liquids.
5
About the NexWave
The NexWave is a mulple-mode smulator which allows users a choice of treatment
opons. This device incorporates Interferenal Current (IFC), Transcutaneous
Electrical Nerve Smulaon (TENS), and Neuromuscular Electrical Smulaon (NMES).
Interferenal Current (IFC)
The le 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 dierence frequency which is felt during treatment. IFC therapy requires the
use of both channels (four electrodes).
Transcutaneous Electrical Nerve Smulaon (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. Paents can use one or two channels (two or four electrodes) for TENS
therapy.
Neuromuscular Electrical Smulaon (NMES)
NMES delivers electrical impulses to muscle motor points at a frequency of 35 Hz. The
smulaon is set by the user at a level to cause muscle contracon. There are three
dierent programs to choose from and each program has a preset smulaon “On
Time” of 10 seconds. The “rest period” (no smulaon) varies from 10 seconds to 30
seconds depending on which program is used. The 10:10 program seng has a rest
period of 10 seconds, the 10:20 program seng has a rest period of 20 seconds, and
the 10:30 program seng has a rest period of 30 seconds. For all programs, the
smulaon ramp up me is 3 second and the ramp down is 1 seconds. Channel 1 and
Channel 2 have the same “On” and “O” Times and when used together will operate
simultaneously.
Important: This device must be ordered or prescribed by a licensed physician.

6
Safety Informaon
· Equipment Classicaon
As per the Internaonal Electrotechnical Commission standard IEC 60601-1, and
the European standard EN 60601-1, Medical Electrical Equipment, General
Requirements for Basic Safety and Essenal Performance, the NexWave is
classied as follows:
· Type BF Equipment
A Type BF piece of equipment is one that provides a parcular degree of
protecon against electric shock, parcularly regarding allowable leakage
current. Type BF applied part is one that is oang above ground and is
isolated from all other parts of the equipment.
· Internally Powered Equipment
When the NexWave is powered by the internal, 9 VDC, MN1604, baery it is
classied as Internally Powered Equipment.
· Class II Medical Equipment
When powered by the external, 12 VDC, medical grade, power supply, the
NexWave is classied 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.
· Electromagnec Compability
Conforms to IEC 60601-1-2.
· Temperature
Operang 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 protecon against ingress of
water.
· Flammable Anesthecs
This device is not suitable for use in the presence of a ammable anesthec
mixture with air, or in the presence of a ammable anesthec mixture with
oxygen or nitrous oxide.
43
NexWave
Specicaons and Accessories
Interferenal Current (IFC)
Amplitude: 0-50 mA
Channel 1 frequency: 4000 Hz
Channel 2 frequency: 4001- 4128 Hz
I/F Modes: Low-High, Low, Combo
Muscle Mode: 64 Hz, 6 sec. on, 6 sec. o, ramp up 1 sec., and ramp down 0.5 sec.
Waveforms: Symmetrical biphasic
Transcutaneous Electrical Nerve Smulaon (TENS)
Amplitude: 0-100 mA
Frequency: 1-125 Hz
Pulse Width: 120-300 µs
TENS Modes: Sweep, Low frequency Modulaon, High frequency Modulaon
Waveform: Symmetrical biphasic
Neuromuscular Electrical Smulaon (NMES)
Amplitude: 0-100 mA
Frequency: 35 Hz
Pulse Width: 480 µs
NMES Modes: 30:10, 20:10, 10:10
On-Time: 10 sec.
O-Time: 30, 20, or 10 sec.
Ramp Up: 3 sec.
Ramp Down: 1 sec.
Waveforms: Symmetrical biphasic
Other Specicaons
Treatment mer: 10 to 90 minutes, in 10 minute increments, with no mer seng
Compliance meter: Records total usage me in minutes and number of mes used
Dimensions: 2.9 x 4.6 x 1.0 in.
Weight: 5.8 oz. including baery
Warranty: 5 year manufacturer’s warranty on materials and workmanship
Accessories excluded
Accessories
Lead wires: 104203, lead wire, black, with black pins
104204, lead wire, gray, with red pins
Electrodes: 300027, electrodes, 2” diameter, round, pkg. of four
300100, electrodes, sterile, 2” x 2”, square, pkg. of four
Power supply: 200109, power supply, medical grade, input 100-240 VAC, 50-60 Hz,
0.3 A max., output 12 VDC, 0.5 A max
Baery: 130010, baery, 9 V, alkaline, MN1604

42
Problem Solution
Unit stays on even aer
treatment ends.
Press and release O buon to turn unit o. Otherwise
unit will shut o automacally aer 5 minutes of no
smulaon. Alternavely you can start a new treatment
session aer the last one ends.
Cannot increase level
from its current seng.
Press and release Unlock buon to unlock this safety
feature. Then increase smulaon to the desired level/
intensity. Intensity level is always locked aer 20 seconds
of key press inacvity.
Do not feel the IF beat
frequency in the center of
the four electrodes.
Check that the lead wires are connected correctly to the
electrodes (red opposite each other, black opposite each
other).
Display shows “Check
Connecons” (electrode
alarm).
Check electrode skin contact. Electrodes should be fresh
and sck well. Use water if necessary to soen the gel for
beer contact. Verify that all four electrodes are
connected to lead wires and that both lead wires are
connected to the unit. Connect the bare metal pins
together to short-circuit the outputs. If the electrode
alarm ceases the problem is with the electrode
connecon integrity.
Troubleshooting
When the ON buon is
pressed, a ashing “Lock”
icon appears on the
display and the NexWave
remains unresponsive.
Press and hold the UNLOCK buon for 20 seconds or unl
the “Lock” icon on the display disappears.
NexWave
Troubleshoong
7
Safety Information
· Mode of Operaon
This device is suitable for connuous operaon.
· Symbols
Safety symbols shown on this device above are dened below.
On/O. This symbol indicates that the labeled switch electronically
cycles the DC power on and o 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 instrucon
manual to prevent potenal hazards.
Refer to Instrucon Manual/Booklet. The operator must read,
understand, and follow all instrucons in the accompanying document
including all warnings, cauons, and precauons before using this
medical device.
Type BF Equipment. This symbol indicates that the paent applied
parts (electrodes) are Type BF (oang from ground) oering the user
a specic level of safety.

8
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 collecon administraon or recycling plant) and in
accordance with local ordinances.
Service and Calibraon
· Do not remove the cover. There are no user serviceable parts. Refer all
service to authorized personnel. No modicaon of the equipment is
allowed.
· No preventave inspecons are required. Factory tesng and calibraon
ensure equipment accuracy and response.
41
NexWave
Precauons and Adverse Reacons
All Modes (IFC, TENS, NMES)
Precauons
· Isolated cases of skin irritaon may occur at the site of the electrode placement
following long-term applicaon.
· Eecveness is highly dependent upon paent selecon by a person qualied in
management of pain paents.
· Safety of powered muscle smulators for use during pregnancy has not been
established.
· Cauon should be used for paents with suspected or diagnosed heart problems.
· Cauon should be used for paents with suspected or diagnosed epilepsy.
· Cauon 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 contracon may disrupt
the healing process.
3. Over the menstruang or pregnant uterus
4. Over the areas of the skin which lack normal sensaon.
· Some paents may experience skin irritaon or hypersensivity due to the
electrical smulaon or electrically conducve medium. The irritaon can usually
be reduced by using an alternate conducve medium, or alternate electrode
placement.
· Electrode placement and smulaon sengs should be based on the guidance of
the prescribing physician.
· This device should be kept out of reach of children.
· This device shall be used only with the leads and electrodes recommended for use
by the manufacturer.
· This device shall not be used while driving, operang machinery, or during any
acvity in which involuntary muscle contracons may put the user at undue risk of
injury.
Adverse Reacons
· Skin irritaon and burns beneath the electrodes are potenal adverse reacons.

40
NexWave
Warnings
Neuromuscular Electrical Smulaon (NMES)
Warnings (Connued)
· Smulaon should not be applied over the neck or mouth. Severe spasm of the
laryngeal and pharyngeal muscles may occur and the contracons may be strong
enough to close the airway or cause diculty in breathing.
· Smulaon should not be applied transthoracically in that the introducon of
electrical current into the heart may cause cardiac arrhythmias.
· Smulaon should not be applied transcerebrally.
· Smulaon should not be applied over swollen, infected, or inamed areas of
skin, erupons, e.g. phlebis, thrombophlebis, varicose veins, etc.
· Smulaon should not be applied over, or in proximity to, cancerous lesions.
· This device is capable of generang currents and voltages in excess of 10 mA RMS
and 10 V RMS, respecvely. A yellow LED indicator is provided next to each lead
wire connector to show that the unit is delivering energy for any non-zero value of
smulaon output (1-100 mA).
· Simultaneous connecon of a paent to high frequency surgical equipment may
result in burns at the site of the smulator electrodes and possible damage to the
smulator.
· Operaons within close proximity (within one meter) of shortwave or microwave
therapy equipment may produce instability in the smulaon output.
Safety References
Zynex Medical, Inc. is only responsible for the safety, reliability and funcon of this
device when repairs and adjustments have been made by persons authorized by Zynex
Medical, Inc., and this device is used in accordance with the user’s manual. Repairs
and technical safety tests shall only be performed by authorized personnel.
9
Electrode Connector Plasc Backing
Electrode
IFC modality requires all 4 electrodes (2
channels)
TENS and NMES modalies 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 plasc backing.
Note: Zynex Medical electrodes are recommended for use with the
NexWave. See addional 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.

10
NexWave
Electrode and Lead Wire Setup (connued)
Step 3 Remove each electrode from the plasc 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 paern as shown in the diagram below.
TENS or NMES: Using both channels and crisscrossing the electrodes is
oponal.
IFC
Crisscrossed Paern
TENS or NMES
Up and Down Paern
39
NexWave
Warnings
Neuromuscular Electrical Smulaon (NMES)
Warnings (Connued)
The maximum output power that the NexWave can produce is 0.168 W per
channel into a 1000 Ω load, 0.336 W total.
· Maximum peak output voltage (500 Ω load) = 50 V
· Maximum peak output current (500 Ω load) = 100 mA
· Maximum peak output voltage (1 KΩ load) = 100 V
· Maximum peak output current (1 KΩ load) = 100 mA
· Maximum peak output voltage (2 KΩ load) = 100 V
· Maximum peak output current (2 KΩ load) = 50 mA
· Pulse width range: 480 µs
· Pulse frequency range: 35 Hz
· Maximum RMS voltage (500 Ω load) = 6.48 V
· Maximum RMS current (500 Ω load) = 12.96 mA
· Maximum output power (500 Ω load) = 0.084 W per channel
· Maximum RMS voltage (1 KΩ load) = 12.96 V
· Maximum RMS current (1 KΩ load) = 12.96 mA
· Maximum output power (1 KΩ load) = 0.168 W per channel
· Maximum RMS voltage (2 KΩ load) = 12.96 V
· Maximum RMS current (2 KΩ load) = 6.48 mA
· Maximum output power (2 KΩ load) = 0.084 W per channel
· The safety of NMES devices for use during pregnancy or birth has not been
established.
· This device is not eecve for pain of central origin. (This includes headache.)
· This device should only be used under the connued supervision of a physician.
· This device does not have curave value.
· This device oers symptomac treatment such as suppressing the sensaon of
pain which would otherwise serve as a protecve mechanism.
· The user must keep this 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.
· The long-term eects of chronic electrical smulaon are unknown.
· Smulaon should not be applied over the carod sinus nerves, parcularly in
paents with known sensivity to the carod sinus reex.