Zynex Medical NexWave User Manual

Contact Information & Support

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: info@zynex.com

About the NexWave

The NexWave is a multi-mode stimulator offering Interferential Current (IFC), Transcutaneous Electrical Nerve Stimulation (TENS), and Neuromuscular Electrical Stimulation (NMES) treatment options. It is designed for patient use under the guidance of a licensed physician.

Interferential Current (IFC)

IFC therapy utilizes two channels (four electrodes) to create a difference frequency that is felt during treatment. Channel 1 operates at 4000 Hz, and Channel 2 operates at a slightly higher frequency (4001-4128 Hz).

Transcutaneous Electrical Nerve Stimulation (TENS)

TENS delivers electrical impulses through the skin at frequencies ranging from 1-125 Hz. It can be used for pain relief for durations from 10 minutes to many hours, utilizing one or two channels (two or four electrodes).

Neuromuscular Electrical Stimulation (NMES)

NMES delivers electrical impulses to muscle motor points at 35 Hz to induce muscle contraction. Programs include 10:10, 10:20, and 10:30, with varying rest periods. Stimulation includes a 3-second ramp-up and a 1-second ramp-down.

Important: This device must be prescribed by a licensed physician.

Safety Information

• Equipment Classification: Type BF Equipment, Internally Powered Equipment (when using battery), Class II Medical Equipment (when using AC adapter).
• Electromagnetic Compatibility: Conforms to IEC 60601-1-2.
• Operating Temperature: 0° - 40°C (32° - 104° F).
• Storage Temperature: -20° - 70°C (-4° - 158° F).
• Water Ingress: Ordinary equipment; no protection against water.
• Flammable Anesthetics: Not suitable for use with flammable anesthetic mixtures.

Specifications and Accessories

Interferential Current (IFC)

• Amplitude: 0-50 mA
• Channel 1 Frequency: 4000 Hz
• Channel 2 Frequency: 4001-4128 Hz
• Modes: Low-High, Low, Combo
• Muscle Mode: 64 Hz, 6 sec. on/off, 1 sec. ramp up, 0.5 sec. ramp down
• Waveform: Symmetrical biphasic

Transcutaneous Electrical Nerve Stimulation (TENS)

• Amplitude: 0-100 mA
• Frequency: 1-125 Hz
• Pulse Width: 120-300 μs
• Modes: Sweep, Low frequency Modulation, High frequency Modulation
• Waveform: Symmetrical biphasic

Neuromuscular Electrical Stimulation (NMES)

• Amplitude: 0-100 mA
• Frequency: 35 Hz
• Pulse Width: 480 μs
• Modes: 30:10, 20:10, 10:10
• On-Time: 10 sec.
• Off-Time: 30, 20, or 10 sec.
• Ramp Up: 3 sec.
• Ramp Down: 1 sec.
• Waveforms: Symmetrical biphasic

Other Specifications

• Treatment Timer: 10 to 90 minutes
• Dimensions: 2.9 x 4.6 x 1.0 in.
• Weight: 5.8 oz. (with battery)
• Warranty: 5 year manufacturer's warranty (accessories excluded)

Accessories

• Lead wires: 104203 (black), 104204 (gray)
• Electrodes: 300027 (2" round), 300100 (2"x2" square)
• Power supply: 200109 (100-240 VAC input)
• Battery: 130010 (9V alkaline, MN1604)

Device Controls and Operation

Device Controls

The NexWave device features:

• On/Off Button: Turns the device on or off.
• Modality Buttons (IFC, TENS, NMES): Select the desired treatment mode.
• Intensity Control Buttons (+/-): Adjust stimulation intensity for each channel.
• Treatment Timer Button: Sets the duration of the treatment session.
• Unlock Button: Unlocks controls after a period of inactivity.

Start Treatment

1. Place electrodes on the skin.
2. Turn the device on using the On/Off button.
3. Select the desired Modality (IFC, TENS, or NMES).
4. Press the selected modality button to cycle through programs until the desired program is indicated.
5. Press the Treatment Timer button to set the desired treatment time.

The device is now ready for use.

During Treatment

• Button controls lock after 20 seconds of inactivity. Press the Unlock button to re-enable controls.
• Increase Intensity: Press the Up Intensity button for the desired channel. In IFC mode, either Up button increases intensity.
• Decrease Intensity: Press the Down Intensity button for the desired channel. In IFC mode, either Down button decreases intensity.

Display Alerts

• Check Connections: Indicates improper lead wire or electrode attachment. Verify connections.
• Low Battery: Replace battery or connect AC adapter.
• Locked: Controls are locked; press Unlock button to resume.

Electrode and Lead Wire Setup

Step 1: Preparation

Open the electrode package and remove electrodes. Keep them on the plastic backing.

Step 2: Connecting Lead Wires

Insert lead wire pin connectors into electrode connectors. Use RED lead wires for one side and BLACK lead wires for the other.

Note: IFC modality requires all 4 electrodes (2 channels). TENS and NMES modalities can use 2 or 4 electrodes.

Step 3: Electrode Placement

Remove electrodes from the backing and place them on the treatment site as per the modality selected.

• IFC Modality: Place electrodes in a crisscrossed pattern using RED and BLACK lead wires.
• TENS or NMES: Electrodes can be placed in an up and down pattern. Crisscrossing electrodes is optional.

Preprogrammed Modes

Interferential Current (IFC)

• Low-High: Channel 2 frequency sweeps between 4001-4128 Hz every 15 seconds; Channel 1 is fixed at 4000 Hz.
• Low: Channel 2 frequency sweeps between 4001-4010 Hz every 15 seconds; Channel 1 is fixed at 4000 Hz.
• Combo: Consists of three 2-minute cycles (Low Mode, High Mode, Muscle Mode) that repeat. Muscle Mode cycles channels on/off every 6 seconds.

Transcutaneous Electrical Nerve Stimulation (TENS)

• Sweep: Frequency decreases from 125 Hz to 11 Hz over 4 seconds, with pulse width increasing from 120 μs to 300 μs. Then frequency decreases from 10 Hz to 1 Hz, with constant pulse width. Then frequency increases from 1 Hz to 10 Hz, with constant pulse width. Finally, frequency increases from 11 Hz to 125 Hz, with pulse width decreasing from 300 μs to 120 μs.
• Low Frequency Modulation (Lmd): Frequency sweeps between 66.7-100 Hz over 12 seconds, with pulse width decreasing to 150 μs during sweep up and increasing back to 300 μs during sweep down.
• High Frequency Modulation (Hmd): Similar to Lmd, but with a 2-second frequency shift interval.

Neuromuscular Electrical Stimulation (NMES)

• 30:10: 10 seconds on, 30 seconds off, 35 Hz, 480 μs pulse width, 3 sec ramp-up, 1 sec ramp-down.
• 20:10: Same as 30:10, but with 20 seconds off time.
• 10:10: Same as 30:10, but with 10 seconds off time.

Indications for Use

Neuromuscular Electrical Stimulation (NMES)

• Muscle re-education
• Prevention or retardation of disuse atrophy
• Increasing local blood circulation
• Maintaining or increasing range of motion
• Relaxation of muscle spasms

Transcutaneous Electrical Nerve Stimulation (TENS)

• Management and symptomatic relief of chronic intractable, post-traumatic, and post-surgical pain.

Interferential Current (IFC)

• Management and symptomatic relief of chronic intractable, post-traumatic, and post-surgical pain.

Contraindications

• Do not use with a cardiac demand pacemaker.
• Do not place electrodes where current can be applied to the carotid sinus (neck) or transcerebrally (through the head).
• Do not use for undiagnosed pain syndromes until etiology is established.

Warnings

General Warnings

• When using the external power supply, disconnect it from the AC mains outlet to ensure complete disconnection. Ensure the AC outlet is accessible.
• The device can generate current densities exceeding 2 mA RMS/cm²; use caution.
• Do not exceed 0.5 W/cm² with recommended electrodes (1000 Ω load).
• Maximum stimulation settings vary by electrode size (e.g., 50 mA for 1" round).
• The device is a constant current output device. Output parameters depend on load, pulse width, and frequency.
• The safety of IFC, TENS, and NMES devices during pregnancy or birth has not been established.
• This device is not effective for central pain (e.g., headache).
• Use only under the supervision of a physician.
• This device provides symptomatic relief and does not have curative value.
• Keep out of reach of children.
• Electronic monitoring equipment may not operate properly when the device is in use.
• Long-term effects of chronic electrical stimulation are unknown.
• Do not apply stimulation over the carotid sinus nerves.
• Do not apply stimulation over the neck or mouth, as severe spasms may affect breathing.
• Do not apply stimulation transthoracically to avoid cardiac arrhythmias.
• Do not apply stimulation over swollen, infected, or inflamed skin areas.
• Do not apply stimulation over or near cancerous lesions.
• The device is capable of generating currents and voltages exceeding specified limits; a yellow LED indicates output.
• Simultaneous use with high-frequency surgical equipment may cause burns or damage.
• Operations near shortwave or microwave therapy equipment may cause instability.

Safety References

Zynex Medical, Inc. is responsible for the device's safety and reliability when repairs are performed by authorized personnel and the device is used according to the manual. Technical safety tests must be performed by authorized personnel.

Troubleshooting

• Unit stays on after treatment ends: Press the Off button. The unit will also shut off automatically after 5 minutes of inactivity.
• Cannot increase level: Press and release the Unlock button, then increase intensity. Intensity locks after 20 seconds of inactivity.
• No IFC beat frequency: Check lead wire connections (red opposite red, black opposite black).
• Display shows "Check Connections": Check electrode skin contact and ensure all electrodes are connected to lead wires and the unit. Shorting the outputs can help diagnose the issue.
• "Lock" icon appears, device unresponsive: Press and hold the Unlock button for 20 seconds.

Treatment Protocols (Examples)

Radicular Back Pain-Sciatica (TENS Only)

• Intensity Level: Strong but comfortable.
• Mode: Swp, Lmd, Hmd.
• Electrode Placement: Place electrodes along the spine and pain route.

Lumbar Back Pain Control

• Modality: IFC (LoHi, Low, Cmb) or TENS (Swp, Lmd, Hmd).
• Treatment Time: 40 minutes, 4 times/day (IFC) or as needed (TENS).
• Electrode Placement: Surround the targeted area with pain in the center.

Muscle Spasm Reduction

• Modality: IFC (Cmb).
• Treatment Time: 40 minutes, 3-4 times/day.
• Electrode Placement: Surround the targeted muscle group.

Post-Operative Knee Pain Relief & Edema Reduction

• Intensity Level: Strong but comfortable.
• Modality: IFC (Cmb) or TENS (Swp, Lmd, Hmd).
• Treatment Time: 40 minutes, 4 times/day or as needed.
• Electrode Placement: Place electrodes around the bandaged area, avoiding incisions.

Cervical / Upper Back Pain Control

• Modality: IFC (LoHi, Low, Cmb) or TENS (Swp, Lmd, Hmd).
• Treatment Time: 40 minutes, 4 times/day or as needed.
• Electrode Placement: Surround the targeted area with pain in the center.

Thoracic Back Pain Control

• Modality: IFC (LoHi, Low, Cmb) or TENS (Swp, Lmd, Hmd).
• Treatment Time: 40 minutes, 4 times/day or as needed.
• Electrode Placement: Surround the targeted area with pain in the center.

Foot Pain Control

• Modality: IFC (LoHi, Low, Cmb) or TENS (Swp, Lmd, Hmd).
• Treatment Time: 40 minutes, 4 times/day or as needed.
• Electrode Placement: Surround the targeted area with pain in the center.

Ankle Pain Control

• Modality: IFC (LoHi, Low, Cmb) or TENS (Swp, Lmd, Hmd).
• Treatment Time: 40 minutes, 4 times/day or as needed.
• Electrode Placement: Surround the targeted area with pain in the center.

Shoulder Pain Control

• Modality: IFC (LoHi, Low, Cmb) or TENS (Swp, Lmd, Hmd).
• Treatment Time: 40 minutes, 4 times/day or as needed.
• Electrode Placement: Surround the targeted area with pain in the center.

Elbow Pain Control

• Modality: IFC (LoHi, Low, Cmb) or TENS (Swp, Lmd, Hmd).
• Treatment Time: 40 minutes, 4 times/day or as needed.
• Electrode Placement: Surround the targeted area with pain in the center.

Lateral / Medial Knee Pain Control

• Modality: IFC (LoHi, Low, Cmb) or TENS (Swp, Lmd, Hmd).
• Treatment Time: 40 minutes, 4 times/day or as needed.
• Electrode Placement: Surround the targeted area with pain in the center.

Anterior Knee Pain Control

• Modality: IFC (LoHi, Low, Cmb) or TENS (Swp, Lmd, Hmd).
• Treatment Time: 40 minutes, 4 times/day or as needed.
• Electrode Placement: Surround the targeted area with pain in the center.

Wrist Pain Control

• Modality: IFC (LoHi, Low, Cmb) or TENS (Swp, Lmd, Hmd).
• Treatment Time: 40 minutes, 4 times/day or as needed.
• Electrode Placement: Surround the targeted area with pain in the center.

Hip Pain Control

• Modality: IFC (LoHi, Low, Cmb) or TENS (Swp, Lmd, Hmd).
• Treatment Time: 40 minutes, 4 times/day or as needed.
• Electrode Placement: Surround the targeted area with pain in the center.

Back of Leg Pain Control

• Modality: IFC (LoHi, Low, Cmb) or TENS (Swp, Lmd, Hmd).
• Treatment Time: 40 minutes, 4 times/day or as needed.
• Electrode Placement: Surround the targeted area with pain in the center.

Warranty Information

The NexWave device is warranted against defects in material, workmanship, and structural integrity for five years from the original purchase date, when used under normal domestic conditions. Zynex Medical, Inc. will replace the device at its discretion for issues arising from normal use. This warranty does not cover misuse or use contrary to the operating instructions. Warranty obligations are limited to defective parts replacement. This warranty is valid only for the original purchaser and is not transferable. For warranty service, contact Technical Support.

Waste Electrical and Electronic Equipment (WEEE)

This product may contain hazardous substances and should be disposed of properly at a local waste collection or recycling facility 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 modifications to the equipment are allowed.
• No preventative inspections are required. Factory testing ensures accuracy.