Zynex medical Nexwave User manual

P/N 300400, Rev.13.0

Zynex Medical, Inc.

9555 Maroon Circle

Englewood, CO 80112

USA

Phone: 1-800-495-6670

Fax: 1-800-495-6695

Internet: www.zynex.com

Email: [email protected]

NexWave

User’s Manual

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

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

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.

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.

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.

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.

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

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

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.

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.

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.

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.

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.

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

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.

NexWave

Indicaons for Use

Neuromuscular Electrical Smulaon (NMES)

Indicaons

· Muscle re-educaon

· Prevenon or retardaon of disuse atrophy

· Increasing local blood circulaon

· Maintaining or increasing range of moon

· Relaxaon of muscle spasms

Contraindicaons

· This smulator shall not be used on paents with a cardiac demand pacemaker.

· Electrodes shall not be placed so that current will be applied to the carod sinus

(neck) region or transcerebrally (through the head).

· This smulator shall not be used whenever pain syndromes are undiagnosed unl

eology is established.

Warnings

· When using the separate external power supply, this medical electrical device

does not incorporate a power switch to isolate the system from the AC mains.

Unplug the power cord of the AC adapter from the AC mains outlet in order to

posively disconnect from the AC mains. Ensure that the AC outlet is easily

accessible.

· This device is capable of generang current densies for electrodes exceeding 2

mA rms/cm2 which may require special aenon of the operator.

· Do not exceed 0.5 W/cm2 with recommended electrodes, assuming a load of 1000

Ω.

· 1” round: Maximum smulaon seng = 100 mA

· 2” round: Maximum smulaon seng = 100 mA

· 2” square: Maximum smulaon seng = 100 mA

· Output waveform/power informaon:

When delivering smulaon energy, the NexWave in NMES mode is a constant

current output device. Therefore its output voltage, current, and power are

dependent upon the load as well as the pulse width and frequency of the output

waveform. The maximum peak voltage that the NexWave can produce is 100 V

(1000 Ω load).

NexWave

Electrode and Lead Wire Setup (connued)

Step 4 Plug lead wires into the top of the NexWave while carefully observing their

orientaon. The IFC modality requires both lead wires to be connected

(channel 1 & 2). TENS and NMES modalies require one or both lead wires.

Step 5 Proceed to page 16 to start treatment or page 12 to program device.

Channel 2 Channel 1

NexWave

Device Programming Instrucons

1. Place electrodes on the skin prior to turning on this device.

2. Turn device on by pressing the black On/O buon

3. Select desired Modality by pressing the “IFC”, “TENS”, or “NMES” buon once.

4. Connue to press the selected modality buon unl arrow is next to desired

program.

5. Press Treatment Timer buon unl desired treatment me is set on screen.

Device is now ready to use.

Treatment

Timer Buon

Modality

Buons

On/O

Buon

NexWave

Warnings

Transcutaneous Electrical Nerve Smulaon (TENS)

Warnings (Connued)

· Smulaon shall not be applied transthoracically in that the introducon of

electrical current into the heart may cause cardiac arrhythmias.

· Smulaon shall not be applied transcerebrally.

· Smulaon shall 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 shall 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.

NexWave

Warnings

Transcutaneous Electrical Nerve Smulaon (TENS)

Warnings (Connued)

· 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: 120 - 300 µs

· Pulse frequency range: 1 - 125 Hz

· Maximum RMS voltage (500 Ω load) = 7.07 V

· Maximum RMS current (500 Ω load) = 14.14 mA

· Maximum output power (500 Ω load) = 0.10 W per channel

· Maximum RMS voltage (1 KΩ load) = 14.14 V

· Maximum RMS current (1 KΩ load) = 14.14 mA

· Maximum output power (1 KΩ load) = 0.20 W per channel

· Maximum RMS voltage (2 KΩ load) = 14.14 V

· Maximum RMS current (2 KΩ load) = 7.07 mA

· Maximum output power (2 KΩ load) = 0.10 W per channel

· The safety of TENS 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.

· 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.

NexWave

Preprogrammed Modes

Interferenal Current (IFC)

Mode Descripon

Low-High The frequency of channel 2 sweeps between 4001 Hz and 4128

Hz every 15 seconds, while the channel 1 frequency remains

xed 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

xed at 4000 Hz.

Combo Combo consists of three 2 minute cycles which repeat over the

duraon 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 xed at

4064 Hz, and the frequency of channel 1 is xed at 4000 Hz.

Both channels are cycled on and o simultaneously at 6 second

intervals.

Transcutaneous Electrical Nerve Smulaon (TENS)

Mode Descripon

Sweep The frequency is decreased linearly from 125 Hz to 11 Hz over a

4 second span. During this me, 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 me,

the pulse width is decreased linearly from 300 µs to 120 µs.

Low frequency

Modulaon 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.

High frequency

Modulaon Same as Lmd, but with a frequency shi interval of 2 seconds.

NexWave

Preprogrammed Modes

Neuromuscular Electrical Smulaon (NMES)

Mode Descripon

30:10 Preset 10 seconds on and 30 seconds o me, 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 o me.

10:10 Same as above, but with a 10 second o me.

NexWave

Indicaons for Use

Transcutaneous Electrical Nerve Smulaon (TENS)

Indicaons

· Management and symptomac relief of chronic intractable, post-traumac and

post-surgical pain.

Contraindicaons

· This smulator shall not be used on paents with a cardiac demand pacemaker.

· Electrodes shall not be placed so that current will be applied to the carod sinus

(neck) region or transcerebrally (through the head).

· This smulator shall not be used whenever pain syndromes are undiagnosed unl

eology is established.

Warnings

· When using the separate external power supply, this medical electrical device

does not incorporate a power switch to isolate the system from the AC mains.

Unplug the power cord of the AC adapter from the AC mains outlet in order to

posively disconnect from the AC mains. Ensure that the AC outlet is easily

accessible.

· This device is capable of generang current densies for electrodes exceeding 2

mA RMS/cm2 which may require special aenon of the operator.

· Do not exceed 0.5 W/cm2 with recommended electrodes, assuming a load of 1000

Ω.

· 1” round: Maximum smulaon seng = 100 mA

· 2” round: Maximum smulaon seng = 100 mA

· 2” square: Maximum smulaon seng = 100 mA

· Output waveform/power informaon:

When delivering smulaon energy, the NexWave in TENS mode is a constant

current output device. Therefore its output voltage, current, and power are

dependent upon the load as well as the pulse width and frequency of the output

waveform. The maximum peak voltage that the NexWave can produce is 100 V

(1000 Ω load). The maximum peak current that the NexWave can produce is 100

mA (1000 Ω load). The maximum output power that the NexWave can produce is

0.15 W per channel into 1000 Ω load, 0.30 W total.

NexWave

Warnings

Interferenal Current (IFC)

Warnings (Connued)

· Smulaon shall not be applied transcerebrally.

· Smulaon shall 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 shall 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 (1-50 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.

Uses electricity from wall socket

instead of 9 V baery

A/C Adapter Input

Channel 2 Intensity Control

Up and Down Buon

Channel 1 Intensity Control

Up and Down Buon

Lead Wire Connecon

Channel 1

Lead Wire Connecon

Channel 2

Turns Unit On/O

On/O Buon

IFC, TENS, NMES

Modality Buons

Unlock Buon Controls

Unlock Buon

Treatment Timer

Treatment Timer Buon

Display

NexWave

Device Controls

NexWave

Device Operang Instrucons

Start Treatment:

Before starng 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/O buon once.

2. Increase intensity by pressing Channel 1 Up buon unl a strong but comfortable

smulaon level is felt. Repeat for Channel 2 if both lead wires are aached and

device is in TENS or NMES mode.

3. Once desired level of smulaon is set, the unit will automacally shut o at the

preset treatment me shown on the display. If Treatment Timer has been set to

“No Timer” then this device will need to be shut o manually. Refer to

Programming Instrucons on page 12 to adjust Treatment Timer.

4. To turn o device manually, press the On/O buon.

During Treatment:

IMPORTANT: Buon controls lock aer 20 seconds of inacvity. To unlock buon

controls, press Unlock buon.

Increase Intensity:

To increase intensity, press the Up Intensity buon for the desired channel unl the

preferred level of smulaon is felt. While in IFC mode, pressing either Up Intensity

buon will increase the smulaon level.

Decrease Intensity:

To decrease intensity, press the Down Intensity buon for the desired channel unl

the preferred level of smulaon is felt. While in IFC mode, pressing either Down

Intensity buon will decrease the smulaon level.

Display Alerts:

Check Connecons: Lead wire(s) and/or electrode(s) may not be aached properly.

Check all connecons and try again (see page 42). If problem persists, call Technical

Support (see page 4).

Low Baery: Replace baery immediately or connect the A/C adapter.

Locked: Smulaon level and mode cannot be changed unl Unlock buon is pressed.

NexWave

Warnings

Interferenal Current (IFC)

Warnings (Connued)

· Maximum peak output voltage (500 Ω load) = 25 V

· Maximum peak output current (500 Ω load) = 50 mA

· Maximum peak output voltage (1 KΩ load) = 50 V

· Maximum peak output current (1 KΩ load) = 50 mA

· Maximum peak output voltage (2 KΩ load) = 50 V

· Maximum peak output current (2 KΩ load) = 25 mA

· Frequency: 4000 Hz nominal

· Duty Cycle: 100%

· Maximum RMS voltage (500 Ω load) = 25 V

· Maximum RMS current (500 Ω load) = 50 mA

· Maximum output power (500 Ω load) = 1.25 W per channel

· Maximum RMS voltage (1 KΩ load) = 50 V

· Maximum RMS current (1 KΩ load) = 50 mA

· Maximum output power (1 KΩ load) = 2.5 W per channel

· Maximum RMS voltage (2 KΩ load) = 50 V

· Maximum RMS current (2 KΩ load) = 25 mA

· Maximum output power (2 KΩ load) = 1.25 W per channel

· The safety of Interferenal 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 trained

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.

· 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.

NexWave

Indicaons for Use

Interferenal Current (IFC)

Indicaons

· Management and symptomac relief of chronic intractable, post-traumac and

post-surgical pain.

Contraindicaons

· This smulator shall not be used on paents with a cardiac demand pacemaker.

· Electrodes shall not be placed so that current will be applied to the carod sinus

(neck) region or transcerebrally (through the head).

· This smulator shall not be used whenever pain syndromes are undiagnosed unl

eology is established.

Warnings

· When using the separate external power supply, this medical electrical device

does not incorporate a power switch to isolate the system from the AC mains.

Unplug the power cord of the AC adapter from the AC mains outlet in order to

posively disconnect from the AC mains. Ensure that the AC outlet is easily

accessible.

· This device is capable of generang current densies for electrodes exceeding 2

mA RMS/cm2 which may require special aenon of the operator.

· Do not exceed 0.5 W/cm2 with recommended electrodes, assuming a load of 1000

Ω.

· 1” round: Maximum smulaon seng = 50 mA

· 2” round: Maximum smulaon seng = 50 mA

· 2” square: Maximum smulaon seng = 50 mA

· Output waveform/power informaon:

When delivering smulaon energy, the NexWave in IFC mode is a constant

current output device. Therefore, its output voltage, current, and power are

dependent upon the load as well as the pulse width and frequency of the output

waveform. Using the supplied AC adapter to power the unit, the maximum peak

voltage that the NexWave can produce is 50 V (1000 Ω load). The maximum peak

current that the NexWave can produce is 50 mA (1000 Ω load). The maximum

output power that the NexWave can produce is 2.5 W per channel into a 1000 Ω

load, 5 W total.

PAIN CONTROL - TENS ONLY

INTENSITY LEVEL:

The smulaon 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-Sciaca

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 shown below.

Opon 1 Opon 2

PAIN CONTROL

INTENSITY LEVEL:

The smulaon level should be set to a strong, but comfortable strength.

DEVICE SET-UP:

Modality Mode Treatment Time

________________________________________________________________________________________________________________________________________________________________________

IFC LoHi, Low, Cmb 40 minutes 4 mes/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 paern depicted on gure to the le.

TENS Modality

Place the electrodes with the RED and

BLACK ends of the lead wires according

to paern depicted on gure to the le.

Using both channels and crisscrossing

the electrodes is oponal when using the

TENS modality.

Lumbar Back

SPASM REDUCTION

Muscle spasm may be reduced by intenonally faguing the associated muscle or

muscle group.

INTENSITY LEVEL:

The smulaon level should be set to a strong, but comfortable strength.

DEVICE SET-UP:

Modality Mode Treatment Time

________________________________________________________________________________________________________________________________________________________________________

IFC Cmb 40 minutes 3 to 4 mes/day

NMES 10:10 on: o me 40 minutes 3 to 4 mes/day

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

paern depicted on gure below.

NMES Modality

Place the electrodes with the RED and BLACK ends of the lead wires according to

paern depicted on gure below.

Muscle Spasm

PAIN RELIEF & EDEMA REDUCTION

Post-operave pain and swelling may be reduced by the applicaon of electrical

smulaon immediately aer surgery and connuing as needed.

INTENSITY LEVEL:

The smulaon level should be set to a strong, but comfortable strength.

DEVICE SET-UP:

Modality Mode Treatment Time

________________________________________________________________________________________________________________________________________________________________________

IFC Cmb 40 minutes 4 mes/day

TENS Swp, Lmd or Hmd As needed for pain & swelling

ELECTRODE PLACEMENT

When applying electrodes in the operang room, sterile electrodes must be used and

placed away from incisions as shown below. Electrodes applied outside the operang

room do not need to be sterile and should be placed around the bandaged area in the

paern shown below. Electrodes should surround the targeted treatment site with

area of pain located in the center of the electrode area.

Protocol based on the following study: The Eects of Home Interferenal Therapy on Post-Operave Pain, Edema, and Range of Moon of the

IFC Modality

Place the electrodes with the RED and BLACK ends of the lead wires according to

paern depicted on gure below.

TENS Modality

Place the electrodes with the RED and BLACK ends of the lead wires according to

paern depicted on gure below. Crisscrossing the electrodes is oponal when using

TENS modality.

Post-Operave Knee

PAIN CONTROL

INTENSITY LEVEL:

The smulaon level should be set to a strong, but comfortable strength.

DEVICE SET-UP:

Modality Mode Treatment Time

________________________________________________________________________________________________________________________________________________________________________

IFC LoHi, Low, Cmb 40 minutes 4 mes/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 paern depicted on gure to the le.

TENS Modality

Place the electrodes with the RED and

BLACK ends of the lead wires according

to paern depicted on gure to the le.

Using both channels and crisscrossing

the electrodes is oponal when using the

TENS modality.

Cervical / Upper Back

PAIN CONTROL

INTENSITY LEVEL:

The smulaon level should be set to a strong, but comfortable strength.

DEVICE SET-UP:

Modality Mode Treatment Time

_______________________________________________________________________________________________________________________________________________________________________

IFC LoHi, Low, Cmb 40 minutes 4 mes/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 paern depicted on gure to the le.

Thoracic Back

TENS Modality

Place the electrodes with the RED and

BLACK ends of the lead wires according

to paern depicted on gure to the le.

Using both channels and crisscrossing

the electrodes is oponal when using the

TENS modality.

PAIN CONTROL

INTENSITY LEVEL:

The smulaon level should be set to a strong, but comfortable strength.

DEVICE SET-UP:

Modality Mode Treatment Time

________________________________________________________________________________________________________________________________________________________________________

IFC LoHi, Low, Cmb 40 minutes 4 mes/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.

Foot

IFC Modality